A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients Undergoing Complex Cardiac Surgery Procedures
Phase: PHASE3
Conditions: Anemia
Sponsor: Cerus Corporation

 
Cerus Corporation 
CLI 00125 
ReCePI PROTOCOL, v8.0 
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, 
Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood 
System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery 
Procedures (the ReCePI study) 
 
April 6, 2023 
 
 
 
NCT03459287 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
CLI 00125, v8.0 
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not subject to disclosure without express written consent from Cerus Corporation. 
PROTOCOL 
TITLE: 
A Randomized, Double-Blinded, Controlled, Parallel Group, 
Non-inferiority, Phase III Study to Evaluate the Efficacy and 
Safety of the INTERCEPT Blood System for Red Blood Cells 
in Patients undergoing Complex Cardiac Surgery Procedures 
(the ReCePI study)  
SPONSOR: 
Cerus Corporation 
1220 Concord Avenue 
Concord, CA 94520, USA 
(925) 288-6000 
PROTOCOL NUMBER: 
CLI 00125 
DATE: 
April 6, 2023 Amendment 8.0 
IDE NUMBER: 
BB-IDE 13803 
MEDICAL MONITOR: 
Christine Ernst, MD, PhD 
Sr. Director, Clinical Research and Medical Affairs  
Cerus Corporation 
(925) 288-6259 
 
 
Richard J. Benjamin MD, PhD 
Chief Medical Officer 
Cerus Corporation 
(925) 288-6020 
MANAGER (or sponsor 
contact): 
Paulette Niemyski 
Sr. Clinical Trial Manager 
Cerus Corporation 
(925) 288-6000 
 
 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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SYNOPSIS 
Name of Sponsor/Company: 
Individual Study Table  
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of the Dossier 
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CERUS CORPORATION 
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Red Blood Cells treated with the 
INTERCEPT Blood System 
Title of Study:  
A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III 
Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red 
Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI 
study)  
Investigators / Study Sites/Blood Centers: 15-20 clinical sites and up to 4 blood centers   
Publication (reference): NA 
Studied period (years): To Be Determined (TBD) 
  Date of first enrollment:  November 21, 2018 
  Date of last completed: TBD 
Phase of development:  3 
Objective:  
The objective of this study is to evaluate the efficacy and safety of red blood cell (RBC) transfusion for 
support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment 
following transfusion of RBCs treated with the INTERCEPT Blood System for Red Blood Cells compared 
to patients transfused with conventional RBCs. 
Methodology:   
The study is a prospective, multicenter, randomized, double-blinded, active controlled, parallel-design, 
non-inferiority study. 
Primary Endpoints: 
Primary 
Efficacy: 
The primary efficacy endpoint is the proportion of patients who have received at least one study transfusion 
with a diagnosis of renal impairment defined as: 
• Any raised serum creatinine (sCr) level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 
26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of surgery. 
Safety: 
The primary safety endpoints are:  
• Proportion of patients with any treatment-emergent adverse events (TEAEs) possibly, probably or 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
CLI 00125, v8.0 
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not subject to disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
Referring to Part  
of the Dossier 
(For National Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Red Blood Cells treated with the 
INTERCEPT Blood System 
definitely related to study RBC transfusion through 28 days after the last study transfusion; and 
• Proportion of patients with treatment-emergent antibodies with confirmed specificity to INTERCEPT  
RBCs by the end of study (i.e., 75±15 days after the last study transfusion).  
Study Procedures: 
Screening/Recruitment 
In order to minimize the number of patients who enroll in the study but do not require RBC transfusion, only 
patients with a relatively high likelihood to receive a RBC transfusion as determined by the Investigator (e.g., 
patients receiving aspirin, clopidogrel (or analogs) and/or GPIIb/IIIa inhibitors), or patients with a TRUST 
Score of >3 will be eligible for enrollment. Patients ≥11 years of age undergoing complex cardiac surgery may 
be identified through pre-operative scheduling procedures in advance of their surgery.  
Patients undergoing urgent or emergent cardiac surgery are eligible for the study, subject to institutional 
review board (IRB) approval of an appropriate informed consent process. 
All potentially eligible patients will be approached for study consent/assent within 30 days prior to their 
surgical procedure. Subjects who consent/assent to the study will be assigned a subject ID number and undergo 
screening.  
Screening will include documentation of the patient’s pre-surgical exposure to radiographic contrast media and 
number of prior pregnancies (females). Screening data may be derived from the medical record when 
performed within 30 days prior to their surgical procedure. Eligibility status and other study data including all 
TRUST components will be entered into the clinical database via an electronic data capture (EDC) system 
using electronic case report forms (eCRFs). Patients who fail eligibility for any or multiple inclusion/exclusion 
criteria may be rescreened for eligibility closer to the time of surgery. 
Randomization and Blinding 
Eligible subjects will be randomized up to 7 days before or on the day of scheduled surgery (Day 0). An 
Interactive Web Response System (IWRS) will be used for electronic randomization of eligible patients. 
Randomization (in 1:1 ratio for Test:Control) stratified by site, pre-existing renal impairment (baseline sCr 
≥1.2 mg/dL vs. < 1.2 mg/dL), and cardiac surgery group (more at risk for renal complications vs. less at risk) 
will be employed. Screened subjects who receive a red cell transfusion prior to randomization will no longer 
be considered for randomization, and their participation in the study will end. Patients may be rescreened for 
eligibility closer to the time of surgery. 
Treatment  
Once a subject is randomized, only study RBCs (Test or Control, per the subject’s randomization) should be 
dispensed and transfused during the acute transfusion support period (Day 0 to Day 7 post surgery, hospital 
discharge, or death, whichever is first), as clinically indicated and determined by the treating physician.  
In rare exceptions where study RBCs are unavailable or patient’s need for RBC transfusions exceeds the 
quantity of study RBCs in inventory at the hospital blood bank (e.g., during a Massive Transfusion Protocol), a 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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(For National Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
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Page:  
 
Red Blood Cells treated with the 
INTERCEPT Blood System 
transfusion using non-study RBC (conventional) may be given to provide the patient with an appropriate and 
necessary treatment. In this case, a protocol deviation should be documented.  If a study RBC transfusion is 
given after randomization before surgery commences, a protocol deviation should also be documented.   
Treatment assessments will be divided into an acute transfusion support period starting the day of surgery 
(Day 0 up to Day 7) during which study RBC (Test or Control) are administered, a post-surgical follow-up 
period of a minimum of 28 days after the last study transfusion to collect additional safety data, a clinical 
assessment at day 30 after surgery specifically for mortality and RRT status, and a visit at day 75 (±15) after 
the last study transfusion to assess mortality and RRT status, and collect samples for serological screening for 
antibodies specific to INTERCEPT RBCs. 
In all patients, anesthesia and surgical procedures will be performed according to the local standards of care. 
Following the acute transfusion support period, subjects may receive conventional RBC components if 
additional transfusions are needed, as indicated by their treating physician.  
Study Assessments: Monitoring and Follow-up 
Baseline through Acute Transfusion Support Period (Pre-Op Day -1 up to Post-Op Day 7) 
A screen for antibodies specific for INTERCEPT RBCs should be performed every time that a routine IAT is 
performed during the acute 7-day study transfusion period. 
A blood sample for sCr will be taken at 48 ±4 hours after completion of surgery for both transfused and non-
transfused subjects., A sCr will be determined on a daily basis during the acute transfusion support period up 
to 7 days post-surgery. Other parameters including additional sCr will be collected on eCRFs only when 
available in the medical record.  
Randomized subjects who do not receive an RBC transfusion following randomization within the first 48 
hours after surgery will be discontinued from the study and replaced.  
Daily sCr assessments  will be recorded up to and including  48 ±4 hours for transfused and non-transfused 
subjects. Other post baseline laboratory parameters and adverse events (AEs) will not be collected for non-
transfused subjects. Vital status will be reported for randomized and non-transfused subjects at the time of 
discontinuation. 
Hemodynamic and laboratory measures will be assessed pre-operatively (Day -1, Baseline) and daily as 
available in the medical record from post-operative Day 1 through Day 7, hospital discharge or death, 
whichever occurs first. If a subject is discharged prior to Day 7 but returns to the study site for a standard of 
care visit on Day 7, blood samples should be obtained on that day for a complete blood count and sCr 
determination.  
Hemodynamic parameters that will be collected if available, include heart rate, blood pressure, mean arterial 
pressure, central venous pressure (CVP), and peripheral oxygen saturation via pulse oximetry probe. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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not subject to disclosure without express written consent from Cerus Corporation. 
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Individual Study Table  
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(For National Authority  
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Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Red Blood Cells treated with the 
INTERCEPT Blood System 
Laboratory parameters that will be captured on eCRFs include BUN, creatinine , AST, ALT, fibrinogen, 
bilirubin, troponin, hemoglobin, and platelet counts.  
Transfusion reactions (TRs), adverse events (AEs) and serious adverse events (SAEs) will be assessed on a 
daily basis and documented in the eCRF from the start of surgery or the start of the first study transfusion 
(whichever is first) through post-operative Day 7 and as available through day 28 after the last study 
transfusion.  Vital status will be reported for randomized and non-transfused subjects at the time of 
discontinuation. 
NOTE: The following applies to randomized transfused subjects only. 
Post-operative Day 8 (or Post-discharge, if earlier) through 28 Days After Last Study Transfusion. Subjects 
will be monitored for TRs, AEs and SAEs following the 7-day acute transfusion support period, through 28 
days after the last study transfusion or death, whichever occurs first, according to the local standard of care. In 
an outpatient setting, weekly telephone surveillance calls to the subject will be performed in order to collect 
safety events until the next follow-up visit. 
28 (±3) Days After Last Study Transfusion or Premature Discontinuation from study. 
Subjects who have been discharged should be scheduled for the follow up visit 28 (±3) days after the last study 
transfusion to obtain additional safety information, including patient-reported AEs/ SAEs; laboratory results 
including sCr, DAT/ IAT; a sample for HLA antibodies and antibodies specific to INTERCEPT RBCs will be 
obtained. All randomized subjects who receive any study RBC transfusion must have their vital status 
documented at this visit, or earlier, if the subject dies prior to the visit. If a subject has been discharged, other 
safety information (e.g., AEs and SAEs) may be obtained through medical records, the subject’s physician, or 
a telephone interview with either the subject or a family member.   
30 Days After Surgery 
All randomized subjects who receive a study RBC transfusion must have their vital status and need for RRT 
(defined as hemodialysis or peritoneal dialysis) documented at Day 30 after surgery. RRT that is provided 
prophylactically during surgery while patient is on a bypass machine (the pump), does not meet this endpoint. 
The vital status and RRT assessment on Day 30 can be performed either from the medical records, from a 
phone call to the subject or family, or during the visit 28±3 days after the last study transfusion (only if the last 
study transfusion was given at day 2 or later in the acute transfusion support period). 
End of Study: 75 (±15 Days) After last Study Transfusion 
75 (±15) days after the last study transfusion (End of Study), serum samples for antibodies specific for 
INTERCEPT RBCs will be obtained, either in hospital, at a clinic visitor or offsite. Mortality and the need for 
RRT will be assessed. 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
CLI 00125, v8.0 
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not subject to disclosure without express written consent from Cerus Corporation. 
Name of Sponsor/Company: 
Individual Study Table  
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of the Dossier 
(For National Authority  
 Use only) 
CERUS CORPORATION 
Name of Finished Product:   
Volume: 
 
Not applicable 
Name of Active Ingredient:  
Page:  
 
Red Blood Cells treated with the 
INTERCEPT Blood System 
Data and Safety Monitoring Board (DSMB) 
The study will be monitored by an independent Data and Safety Monitoring Board (DSMB). The primary 
mission of the DSMB is to ensure patient safety and review protocol compliance for data collection. The 
DSMB will be assembled by the Sponsor and composed of transfusion medicine and other experts as per the 
DSMB charter. DSMB members will be independent of the Sponsor. 
Interim Analysis and Early Stopping Rule 
Aside from the blinded interim analysis for sample size re-estimation performed in October 2021, no other 
interim analysis is planned for this study to compare treatment differences with respect to efficacy or safety at 
any time prior to the completion of the study.  Specific stopping rules, defined for safety considerations, are 
defined in Section 4.6 of the protocol. 
Number of patients:  
A total of at least 292 evaluable, randomized and transfused patients, 146 per arm, are planned to generate 
sufficient efficacy and safety data for the Test and Control components in patients undergoing cardiac surgery 
procedures.  
For the primary efficacy endpoint, the proportion of patients with a ∆sCr ≥0.3 mg/dL from pre-surgery 
baseline to within 48±4 hours after surgery, a non-inferiority test will be conducted to assess for treatment 
difference (Test − Control).  By assuming an event rate of 30% in the Control group and no more than 50% 
increase from the Control rate as the non-inferiority margin, a sample size of 292 patients (146 per arm) will 
provide approximately 80% power to declare non-inferiority at the two-sided 0.05 alpha level, assuming the 
true treatment difference is zero.  
Diagnosis and main criteria for inclusion:  
Inclusion criteria: 
1. Age ≥ 11 years of age 
2. Weight ≥ 40 kg 
3. Scheduled complex cardiac surgery or thoracic aorta surgery. The procedure may be performed either 
on or off cardiopulmonary bypass machine (CBP or “pump”). For the purposes of this protocol 
“Repeat procedure” means that the subject had a previous cardiac surgery. Procedures that qualify as 
complex cardiac surgery include but are not limited to, the following: 
• Single Vessel Coronary Artery Bypass Graft, first or repeat procedure 
• Multiple Coronary Artery Bypass Grafts, first or repeat procedure 
• Single Valve Repair or Replacement, first or repeat procedure 
• Multiple Valve Repair or Replacement, first or repeat procedure 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Not applicable 
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Red Blood Cells treated with the 
INTERCEPT Blood System 
• Surgery involving both Coronary Artery Bypass Graft(s) and Valve Repair(s), first or repeat 
procedure 
• One or more of the following procedures, with or without Coronary Bypass Graft(s): 
o 
left ventricular aneurysm repair 
o 
ventricular and/or atrial septal defect repairs  
o 
Batista procedure (surgical ventricular remodeling)  
o 
surgical ventricular restoration  
o 
congenital cardiac defect repair 
o 
aortic procedures  
o 
other cardiac surgery or thoracic aorta surgery types with a high probability of bleeding. 
4. TRUST probability score (Alghamdi, Davis et al. 2006) ≥ 3, or currently on a regimen of aspirin (any 
dose), clopidogrel (or analogs) and/or GPIIb/IIIa inhibitors or at a high probability for need of a 
transfusion during or after surgery at the discretion of the Investigator   
5. Female subjects of child-bearing potential must meet the 2 criteria below at screening: 
• Negative serum or urine pregnancy test  
• Use at least one method of birth control that results in a low failure rate (i.e., less than 1% per 
year) when used consistently and correctly such as implants, injectables, combined oral 
contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner  
6. Signed and dated informed consent/assent form. 
 
Exclusion criteria: 
1. Confirmed positive baseline serum/plasma antibody specific to INTERCEPT RBCs (S-303 specific 
antibody) screening panel prior to randomization.  
2. Pregnant or breast feeding 
3. Refusal of blood products or other inability to comply with the protocol in the opinion of the 
Investigator or the treating physician 
4. Treatment with any medication that is known to adversely affect RBC viability, such as, but not 
limited to dapsone, levodopa, methyldopa, nitrofurantoin, and its derivatives, phenazopyridine and 
quinidine.  
5. Planned cardiac transplantation 
6. Active autoimmune hemolytic anemia  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Red Blood Cells treated with the 
INTERCEPT Blood System 
7. Left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) support 
pre-operatively or planned need post-operatively 
8. Cardiogenic shock requiring pre-operative placement of an intra-aortic balloon pump (IABP) (NOTE: 
IABP done for unstable angina or prophylactically for low ejection fraction is not excluded). 
9. Planned use of autologous or directed donations. 
10. RBC transfusion during current hospitalization prior to enrollment and randomization (within 7 days). 
11. Participation in an interventional clinical study concurrently or within the previous 28 days.  This 
includes investigational blood products, pharmacologic agents, imaging materials (including dyes), 
surgical techniques, or devices.  Observational studies of FDA cleared or approved products or 
nutrition, psychology, or socioeconomic issues are not grounds for exclusion. 
12. Patients with a current diagnosis of either chronic kidney disease or acute kidney injury and with sCr 
≥1.8 mg/dL at screening and patients requiring RRT. (NOTE: If sCr at screening is <1.8 mg/dL, a 
patient with a diagnosis of chronic or acute kidney injury alone is not excluded). 
13. Patients with a current diagnosis of either chronic or acute hepatic insufficiency and with a total serum 
bilirubin ≥ 2.0 mg/dL (≥34.2 µmol/L). (NOTE: If total serum bilirubin at screening is <2.0 mg/dL, a 
patient with a diagnosis of chronic or acute hepatic failure alone is not excluded). 
14. Pre-existing antibody(ies) to RBC antigens that may make the provision of compatible study RBC 
components difficult. 
15. History of TRs requiring washed RBCs, volume reduced RBC, or RBCs with additive solution 
removed. 
16. Patients with documented IgA deficiency or a history of severe allergic reactions to blood products. 
17. Patients who require gamma-irradiated RBC blood components. 
18. Positive DAT as defined below: 
A polyspecific DAT reaction strength > 2+, or 
A polyspecific DAT (any strength) in conjunction with pan-reactivity with a commercial IAT 
antibody screening panel that precludes the identification of underlying alloantibodies or indicates the 
presence of autoantibody. 
Test product, dose and mode of administration:  
The test device is the INTERCEPT Blood System for RBC. The INTERCEPT treatment process uses 
amustaline and glutathione together with a processing solution in a single-use disposable set and results in 
pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The 
INTERCEPT treatment will be performed on leukoreduced RBC components prepared from whole blood 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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not subject to disclosure without express written consent from Cerus Corporation. 
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 Use only) 
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Red Blood Cells treated with the 
INTERCEPT Blood System 
collections and suspended in AS-5 additive solution within 24 hours of collection.  The test component is 
allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6° for up to 35 days post-donation 
and administered intravenously.  The treating physician will determine dose and schedule of RBC transfusions. 
Control product, dose and mode of administration:  
The control transfusion component is a conventional leukoreduced RBC component in an FDA approved 
additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered 
intravenously. The Control RBC components will be handled and labeled in a manner to maintain blinding. 
The treating physician will determine dose and schedule of RBC transfusions.  
Criteria for evaluation:  
Efficacy:  
The primary efficacy endpoint is the proportion of patients, who have received at least one study transfusion 
with a diagnosis of renal impairment defined as: 
• Any raised sCr level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL (or 26.5 µmol/L) from 
the pre-surgery baseline within 48±4 hours of the end of surgery. 
If any subject meets this criterion before receiving a study transfusion, that particular event will not be 
included in this analysis.   
Secondary efficacy outcome measures include: 
• The proportion of patients with a diagnosis of stage I, II or III Acute Kidney Injury (KDIGO 2012) 
based on changes in sCr levels from pre-surgery baseline and the need for renal replacement therapy 
(RRT) post-surgery.  
• Mortality or the need for RRT by 30 days post-surgery. 
Safety: 
The primary safety outcome measures are the: 
• Proportion of patients with any treatment-emergent adverse events (TEAEs) possibly, probably or 
definitely related to study RBC transfusion through 28 days after the last study transfusion; and  
• Proportion of patients with treatment emergent antibodies with confirmed specificity to INTERCEPT 
RBCs by end of study (i.e., 75±15 days after the last study transfusion).  
Additional safety assessments will include: 
• Treatment-emergent AEs through 28 days after the last study transfusion. 
• Treatment-emergent SAEs through 28 days after the last study transfusion. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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not subject to disclosure without express written consent from Cerus Corporation. 
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Red Blood Cells treated with the 
INTERCEPT Blood System 
• Transfusion reactions (as defined by the CDC National Healthcare Safety Network [NHSN] 
Hemovigilance Module protocol) through 28 days after last study transfusion. 
• Treatment-emergent immunization to RBC allo-antigens through 28±3 days after the last study 
transfusion.  
• Treatment-emergent immunization to HLA allo-antigens through 28±3 days after the last study 
transfusion. 
Statistical methods: 
For the primary efficacy endpoint, the treatment difference (Test – Control) and its two-sided 95% confidence 
interval (CI) will be estimated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline sCr (sCr ≥1.2 
mg/dL vs. < 1.2 mg/dL) and cardiac surgery group (more at risk for renal complications vs. less at risk) 
performed. The upper bound of the two-sided 95% CI will be compared with the 50% of the observed Control 
rate. Non-inferiority will be achieved if the upper bound is less than the 50% of the observed Control rate.  For 
the non-inferiority test, the null and alternative hypotheses (H0 and H1, respectively) will be formulated as 
follows:𝐻𝐻0: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇−𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶≥50% × 𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶     𝑣𝑣𝑣𝑣.    𝐻𝐻1: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇−𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶< 50% × 𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶,    
where 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 and 𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 are the event rates for Test (INTERCEPT) and Control groups, respectively, and 
𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶is the observed Control rate. 
Same CMH test will be used for assessment of treatment differences for the secondary efficacy endpoints.  As 
a sensitivity analysis, logistic regression will be utilized to estimate the treatment differences after controlling 
for baseline sCr, cardiac surgery group performed and other covariates to be detailed in the statistical analysis 
plan (SAP). Treatment-emergent AEs (defined as AEs with an onset date/time that is on or after the start 
date/time of the first study transfusion) will be summarized by treatment group, system organ class (SOC), and 
preferred term. 
Subgroup analysis by the randomization stratification variables (clinical site, pre-surgery renal impairment, 
and cardiac surgery group) and by demographic variables such as age group (≤18, 19 to 65, and >65 years 
old), sex, and race will be presented for primary and secondary efficacy endpoints.  Additional subgroup 
analysis may also be presented as suggested by the data.  
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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TABLE OF CONTENTS 
SYNOPSIS ..........................................................................................................................2 
1 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .....................15 
2 
BACKGROUND INFORMATION ......................................................................19 
 General .............................................................................................................19 
 Name and Description of the Investigational Product .....................................22 
2.2.1 Description of Investigational Product ................................................22 
 Summary of Nonclinical and Clinical Studies .................................................22 
2.3.1 Safety ...................................................................................................23 
2.3.2 Immunogenicity ...................................................................................23 
2.3.3 Clinical Studies ....................................................................................23 
 Summary of Potential Risks.............................................................................26 
 Description of and Rationale for Treatment ....................................................27 
3 
STUDY OBJECTIVES ..........................................................................................33 
4 
INVESTIGATIONAL PLAN ................................................................................34 
 Endpoints .........................................................................................................34 
4.1.1 Primary Endpoints ...............................................................................34 
4.1.2 Secondary Endpoints ...........................................................................35 
 Study Design ....................................................................................................36 
 Randomization and Blinding ...........................................................................38 
 Treatment .........................................................................................................39 
4.4.1 Test Product .........................................................................................40 
4.4.2 Control (reference) Product .................................................................40 
 Subject Discontinuation ...................................................................................40 
4.5.1 Definitions............................................................................................41 
4.5.1.1 Enrollment Pause ..................................................................41 
4.5.1.2 Clinical Stop..........................................................................41 
4.5.1.3 Rules .....................................................................................41 
 Accountability of Study Product ......................................................................45 
 Source Data ......................................................................................................45 
5 
SELECTION AND WITHDRAWAL OF SUBJECTS .......................................46 
 Subject Inclusion Criteria ................................................................................46 
 Subject Exclusion Criteria ...............................................................................47 
 Subject withdrawal Criteria .............................................................................48 
5.3.1 Discontinuation from study RBC transfusions ....................................48 
5.3.2 Early termination from Study ..............................................................49 
6 
TREATMENT OF SUBJECTS ............................................................................50 
 Treatment Plan .................................................................................................50 
6.1.1 Screening/Randomization (Day -30 to Day 0 Pre-Surgery) ................50 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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6.1.2 Acute Transfusion Support Period (Surgery [Day 0] to Post-
operative Day 7, Hospital Discharge or Death, Whichever is First) ...51 
6.1.3 Post-operative Period (Day 8 [or Post-discharge, if earlier] through 
Day 28 After Last Study Transfusion) .................................................53 
6.1.4 Day 28±3 After Last Study Transfusion or Early Termination ...........53 
6.1.5 Day 30 – After Surgery Assessment ....................................................54 
6.1.6 End of Study (75 ±15 Days After Last Study Transfusion) .................54 
6.1.7 Assessments in Follow-up to a Reactive Antibody Test Specific for 
INTERCEPT RBCs .............................................................................54 
 Concomitant and Excluded Therapy ................................................................54 
 Treatment Compliance .....................................................................................55 
7 
STUDY ASSESSMENTS .......................................................................................56 
 Study Schedule of Assessments .......................................................................56 
 Assessment of Efficacy ....................................................................................65 
7.2.1 Efficacy Parameters .............................................................................65 
7.2.2 Methods and Timing of Efficacy Parameters ......................................65 
 Assessment of Safety .......................................................................................66 
7.3.1 Safety Parameters.................................................................................66 
7.3.1.1 Definition of Adverse Event .................................................66 
7.3.1.2 Definition of Serious Adverse Event ....................................67 
7.3.1.3 Unexpected Adverse Event ...................................................67 
7.3.1.4 Definition of Unanticipated Adverse Device Effects ...........67 
7.3.1.5 Definition of Renal Impairment ............................................68 
7.3.1.6 Definition of Acute Kidney Injury (AKI) .............................68 
7.3.1.7 Renal Replacement Therapy .................................................69 
7.3.1.8 Treatment-emergent HLA antibodies ...................................69 
7.3.1.9 Definition of Culture Proven Sepsis/Septic Shock ...............69 
7.3.1.10 Definition of Transfusion Reaction ......................................69 
7.3.1.11 Suspected Hemolytic and Serologic Transfusion 
Reactions after Enrollment and Transfusion with Study 
RBC Components .................................................................72 
7.3.1.12 Abnormal Test Findings .......................................................77 
7.3.2 Methods and Timing of Safety Parameters ..........................................77 
 Reporting Period ..............................................................................................78 
 Recording and Reporting Adverse Events .......................................................78 
7.5.1 Assessing Severity of an Adverse Event .............................................78 
7.5.2 Assessing Seriousness of an Adverse Event ........................................79 
7.5.3 Assessing Causality of an Adverse Event ............................................79 
7.5.4 Assessing Relationship to the INTERCEPT Blood System Device ....80 
7.5.5 Reporting Requirements ......................................................................80 
7.5.6 Reporting Device Malfunctions ...........................................................81 
 Data and Safety Monitoring Board (DSMB) and Interim AnalysIs ................82 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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8 
STATISTICS ..........................................................................................................83 
 Statistical Methods ...........................................................................................83 
8.1.1 Efficacy Analysis .................................................................................83 
8.1.2 Safety Analyses ....................................................................................83 
8.1.3 Subgroup Analyses ..............................................................................83 
 Determination of Sample Size .........................................................................84 
 Criteria for Termination of the Study ..............................................................84 
 Handling of Dropouts or Missing Data ............................................................84 
 Deviations from the Statistical Plan .................................................................84 
 Selection of Subjects to be Analyzed...............................................................84 
9 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ..................................86 
10 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................87 
 Monitoring .......................................................................................................87 
 Investigational Product ....................................................................................87 
11 
ETHICS ...................................................................................................................88 
 Conduct of the Trial .........................................................................................88 
 Patient Information and Consent .....................................................................88 
 Institutional Review Board (IRB)/Ethics Committee (EC) .............................88 
 Confidentiality .................................................................................................89 
12 
DATA HANDLING AND RECORD KEEPING ................................................90 
 Case Report Forms ...........................................................................................90 
 Record Retention .............................................................................................90 
13 
LITERATURE REFERENCES ............................................................................91 
14 
APPENDICES ........................................................................................................95 
 
APPENDIX  1: Transfusion Risk Understanding Scoring Tool (TRUST) .......................95 
APPENDIX  2: Evaluation of Reactivity with INTERCEPT RBCs .................................97 
APPENDIX  3 CDC National Healthcare Safety Network Biovigilance Component 
Hemovigilance Module Surveillance Protocol v2.5.2 ...................................109 
APPENDIX  4: Common Terminology Criteria for Adverse Events (CTCAE) 
Version 5.0 Published: November 27, 2017 ..................................................140 
 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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LIST OF TABLES 
Table 2.1 Summary of Clinical Studies with INTERCEPT Blood System for RBCs 
Current Process ................................................................................................24 
Table 2.2 Reanalysis of Cerus Studies RBC 3A01 and CLI 00070 Using Renal 
Impairment Based on Change in Serum Creatinine Levels within 48 hours 
of Cardiac Surgery ...........................................................................................31 
Table 4.1 Stopping Rules for INTERCEPT RBC-specific antibodies ..............................43 
Table 7.1a – Screening/Randomization .............................................................................57 
Table 7.1b - Baseline (Pre-Surgery) ..................................................................................58 
Table 7.1c – Acute Transfusion Support Period ................................................................59 
Table 7.1d – Post-Operative Period ...................................................................................61 
Table 7.1e - Follow-up Visits (Day 28±3, 30, and 75±15) ................................................62 
Table 7.2: Hematology and Chemistry Testing- Required (R) results and Where 
Available (WA)a results ...................................................................................63 
Table 7.3 Some Differential Diagnoses of Hemolytic Transfusion Reactions ..................71 
Table 7.4 Severity Assessment of Adverse Events ............................................................79 
Table 7.5 Relationship between Investigational Product and Adverse Events ..................80 
Table 7.6 Cerus Product Safety Contact Information ........................................................81 
 
 
LIST OF FIGURES 
Figure 4.1 Study Design Schematic ...................................................................................36 
Figure 4.2 Study Flowchart................................................................................................37 
 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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1 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AABB 
American Association of Blood Banks 
ADL 
Activities of Daily Living 
AE 
Adverse Event  
AHG 
Anti-human Globulin 
AHTR 
Acute Hemolytic Transfusion Reaction 
AKI 
Acute Kidney Injury 
AKIN 
Acute Kidney Injury Network 
ALP 
Alkaline Phosphatase 
ALT 
Alanine Transaminase 
ANOVA 
Analysis of Variance 
ANCOVA 
Analysis of Covariance 
AS 
Additive Solution 
AST 
Aspartate Aminotransferase 
ATP 
Adenosine Triphosphate 
ATR 
Acute Transfusion Reaction 
BP  
Blood Pressure 
bpm 
Beats per minute 
BUN 
Blood Urea Nitrogen 
BVDV 
Bovine Viral Diarrhea Virus 
C 
 Celsius 
CABG 
Coronary Artery Bypass Graft 
CBC 
Complete Blood Count 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CFU 
Colony Forming Units 
CI 
Confidence Interval 
CLIA 
Clinical Laboratory Improvement Amendments 
CMH  
Cochran-Mantel-Haenszel  
CMV 
Cytomegalovirus 
CPB 
Cardiopulmonary Bypass 
CP2D 
Citrate Phosphate Double Dextrose 
CPD 
Citrate Phosphate Dextrose 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CSF 
Cerebrospinal Fluid 
CTCAE 
Common Terminology Criteria for Adverse Events 
CVP 
Central Venous Pressure 
DAT 
Direct Antiglobulin Test. Also referred to as the direct Coombs test.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Device 
Malfunction 
The failure of a medical device to function according to its requirements.   
DHBV 
Duck Hepatitis B Virus 
DHTR 
Delayed Hemolytic Transfusion Reaction 
dL 
Deciliter 
DNA 
Deoxyribonucleic Acid 
ds DNA 
Double stranded DNA 
2,3-DPG 
2,3-Diphosphoglycerate 
DSMB 
Data and Safety Monitoring Board 
DSTR 
Delayed Serological Transfusion Reaction 
EC 
Ethics Committee 
ECMO 
Extracorporeal Membrane Oxygenation 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EIA 
Emerging Infectious Agents 
EKG 
Electrocardiogram 
EOS 
End of Study 
F 
Fahrenheit 
FDA 
Food and Drug Administration 
FNHTR 
Febrile Non-Hemolytic Transfusion Reaction 
g 
Gram 
GCP  
Good Clinical Practice 
GSH 
Glutathione 
HA 
Hemolytic anemia 
Hb 
Hemoglobin 
HBV 
Hepatitis B Virus 
Hct 
 Hematocrit 
HCV 
Hepatitis C Virus 
HELLP 
A syndrome occurring in pregnancy. A combination of the breakdown of 
red blood cells (hemolysis: the H in the acronym, elevated liver enzymes 
(EL), and low platelet count (LP). 
HIV 
Human Immunodeficiency Virus 
HLA 
Human Leukocyte Antigen 
HR 
Heart rate 
HSV 
Herpes Simplex Virus 
HTR 
Hemolytic Transfusion Reaction 
IABP 
Intra-aortic Balloon Pump 
IAT 
Indirect Antiglobulin Test. Also referred to as the Indirect Coombs Test.  
IBS 
INTERCEPT Blood System (abbreviation used in preceding protocol 
versions) 
ICF 
Informed Consent Form 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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ICH 
International Council on Harmonization 
ICU 
Intensive Care Unit 
IEC 
Independent Ethics Committee 
IgA 
Immunoglobulin A 
IgG 
Immunoglobulin G 
IgM 
Immunoglobulin M 
INTERCEPT 
Blood System for 
RBCs 
Name of the current Cerus’ Investigational device 
INTERCEPT 
RBC(s) 
Red blood cell component (s) that have been processed/treated with the 
INTERCEPT Blood System for Red Blood Cells (also known as 
INTERCEPT RBCs or S-303 (treated) RBCs) 
IP 
Investigational product 
IRB 
Institutional Review Board 
IWRS 
Interactive Web Response System 
KDIGO 
Kidney Disease Improving Global Outcomes 
kg 
Kilogram 
LDH 
Lactate Dehydrogenase 
L 
Liter 
LVAD 
Left Ventricular Assist Device 
mg 
milligram 
mITT 
Modified Intent-to-Treat 
mL 
Milliliter 
mM 
Millimole 
µM 
Micromole 
MI 
Myocardial Infarction 
mm3 
Cubic millimeter 
mm Hg 
Millimeter of mercury 
N 
Number 
NBG 
Normalized Background  
NCI 
National Cancer Institute 
PaCO2 
Partial pressure of carbon dioxide 
PFU 
Plaque Forming Unit 
PP 
Per Protocol  
RBC 
Red Blood Cell 
ReCePI 
Red Cell Pathogen Inactivation (acronym) 
RIFLE 
Risk, Injury, Failure, Loss of kidney function, and End-stage kidney 
disease classification 
RNA 
Ribonucleic Acid 
ROS 
Reactive oxygen species 
RR 
Respiratory rate 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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RRT 
Renal Replacement Therapy 
ssRNA 
Single Stranded Ribonucleic Acid 
S-300 
(N-(9-Acridinyl)-ß-alanine). The primary decomposition product of 
S-303. 
S-303 
Amustaline. [N,N-bis (2-chloroethyl)]-2-aminoethyl 3-[(acridin-9-yl) 
amino] propionate free base. May also refer to S-303 in solution 
(dissolved S-303 2HCl). 
S-303•2HCl 
S-303 in the salt form used for treating RBC components. 
SAG- M  
SAG-Mannitol: an RBC additive solution  
SAE 
Serious Adverse Event 
SD 
Standard deviation 
SCD 
Sickle Cell Disease 
sCr 
Serum creatinine 
SIRS 
Systemic Inflammatory Response Syndrome 
SOC 
System Organ Class (MedDRA) 
SOP 
Standard Operating Procedure 
TACO 
Transfusion Associated Circulatory Overload 
TA-GVHD 
Transfusion Associated Graft versus Host Disease 
TEAE 
Treatment Emergent Adverse Event 
TR 
Transfusion Reaction 
TRALI 
Transfusion Related Acute Lung Injury 
TRS 
Transfusion Related Sepsis 
TRUST 
Transfusion Risk Understanding Screening Tool 
TTI 
Transfusion-Transmitted Infection 
UADE 
Unanticipated Adverse Device Effect 
ULN 
Upper Limit of Normal 
UO 
Urinary output 
U.S. 
United States 
USP 
US Pharmacopeia 
VSV 
Vesicular Stomatitis Virus 
WBC 
White Blood Cells 
WNV 
West Nile Virus 
 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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2 
BACKGROUND INFORMATION 
 
GENERAL 
Red blood cell (RBC) transfusion is a critical supportive therapy for healthcare. 
Patients and physicians assume, when required, blood transfusion will be available 
and safe. However, serious transfusion-transmitted infections (TTI) caused by 
viruses, bacteria and protozoa (Stramer 2009, MacLennan 2006); and fatal 
transfusion complications such as transfusion-associated graft-versus-host disease 
(TA-GVHD) still pose a threat to transfusion recipients (Kopolovic 2015). 
Currently, prevention of TTI includes pre-donation evaluation and selection of low-
risk donors, followed by serologic and/or nucleic acid testing for selected known 
infectious pathogens.  
The advent of testing has greatly reduced TTI from blood products, particularly 
viral disease, and sepsis associated with the transfusion of bacterially contaminated 
red cell blood components is generally regarded as a very rare event. However, from 
1976 through September 1998, 26 fatalities thought to be secondary to contaminated 
whole blood or red cells were reported to the U.S. FDA (Lee 1999). The majority of 
deaths reported to the FDA involved Yersinia enterocolitica. The highest reported 
incidence of Y. enterocolitica contamination was reported in New Zealand, with an 
incidence rate of 1 in 65,000 and a fatality rate of 1 in 104,000 red cell units 
transfused (Theakston et al. 1997). Unrecognized cases, underreporting, and 
regional variation may account for observed differences in this incidence. 
Interestingly, passive reporting studies of bacterially contaminated red cells from 
the United States, France, and the United Kingdom that caused symptoms of 
infection show a relative paucity of Y. enterocolitica cases (Perez et al. 2001, 
Kuehnert et al. 2001, Serious Hazards of Transfusion report for 2000-2001). Of the 
reported deaths, one was due to a coagulase-negative Staphylococcus strain and 
seven were due to a variety of gram-negative organisms (including Serratia 
liquefaciens in three cases). These organisms are all capable of growth at 
refrigerated temperatures (1° to 6°C). Sepsis associated with the transfusion of red 
cells contaminated with gram-negative bacteria is typically severe and rapid in onset 
(Brecher and Hay 2005). Patients frequently develop high fever (temperatures as 
high as 109°F have been observed) and chills during or immediately following 
transfusion. From 1987 to February 1996, 20 recipients of Y. enterocolitica red cells 
were reported to the Centers for Disease Control (Cookson et al, 1996). Twelve of 
the 20 recipients died, and the median time to death was only 25 hours. Of the seven 
who developed disseminated intravascular coagulopathy, six died.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Prospective bacterial cultures of whole blood or red cells, however, have shown a 
much higher incidence of bacterial contamination (Damgaard et al 2015).  The 
organisms commonly cultured are Staphylococcus sp. or Propionibacterium sp.; 
those strains that have been reported to be isolated in association with adverse 
events linked to the transfusion of contaminated red cell concentrates include 
Pseudomonas sp., S. marcescens, Enterobacter sp., Klebsiella sp., S. epidermidis 
and B. cereus (Siblini et al 2004).   
Newly-emerging infectious agents also remain important risks to blood safety. 
Estimates of per-unit and per-patient aggregate infectious risks for conventional 
RBCs, including known and potential emerging infectious agents (EIA, modeled 
based on chikungunya and dengue viruses) were calculated by Kleinman and 
Stassinopoulos (2015).  Minimum and maximum per-unit risks were calculated as 
0.0003% (1/323,000) and 0.12% (1/831), respectively.  The minimum estimate is 
for known lower-risk pathogens while the maximal estimate also includes an EIA 
and endemic area Babesia sp. risk.  For patients with hemoglobinopathies who 
receive repeated RBC transfusions such as sickle cell disease (SCD), at the 
minimum risk level it is estimated that approximately 1/450 (0.22%) of patients will 
acquire an infection during their entire course of transfusion therapy (approximately 
30-50 years); at the maximum risk levels, infections risk increases to 43-45% for 
patients with hemoglobinopathies, or almost 1 in every 2 patients (Kleinman and 
Stassinopoulos 2015). 
Leukoreduced RBC concentrates contain <5 x106 white blood cells (WBC) that may 
induce TA-GVHD and/or alloimmunization to human leukocyte antigen (HLA) 
antigens. Gamma irradiation can effectively prevent TA-GVHD in transfusion 
recipients. However, almost half the cases of TA-GVHD occur in patients in which 
their treating physicians failed to identify risk using current guidelines for blood 
irradiation, leading to substantial morbidity and mortality (Kopolovic 2015). 
Moreover, irradiation adversely affects post-transfusion RBC recovery (Dumont 
2008) and is associated with raised extracellular potassium levels in the transfused 
concentrates.  
To proactively address the risk of TTIs and TA-GVHD, Cerus has developed 
pathogen and leukocyte inactivation technology systems (INTERCEPT Blood 
System™) for platelet and plasma components and is currently developing a system 
for RBC concentrates. These systems use nucleic acid-targeted compounds that 
intercalate into, and upon activation, covalently bind to nucleic acids of viruses, 
bacteria, parasites and leukocytes that may contaminate blood components, and 
form irreversible adducts and crosslinks thus preventing replication and TTI. This 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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process does not depend on or generate reactive oxygen species (ROS) which can 
damage cells and proteins. RBCs do not require nucleic acid for therapeutic function 
and thus retain therapeutic efficacy after pathogen inactivation treatment. 
INTERCEPT treated RBC (INTERCEPT RBCs) components should not require 
gamma irradiation because the treatment process inactivates donor white blood cells 
with a high safety margin (Castro et al. 2016). It is also possible that INTERCEPT 
treatment may interfere with antigen presentation by donor leukocytes, thereby 
reducing the incidence of HLA alloimmunization. 
Conventional leukoreduced RBC concentrates include approximately 20-40 mL of 
residual plasma that contains serum proteins and immunoglobulins; these are 
implicated in allergic TRs and Transfusion Related Acute Lung Injury (TRALI). 
The INTERCEPT RBC process includes a terminal washing step that reduces the 
concentration of plasma proteins and may reduce the incidence of these reactions. 
The INTERCEPT Blood System for RBCs inactivates a variety of bacteria, viruses 
and protozoa. The organisms evaluated to date include examples representing a 
range of different characteristics, such as enveloped (HIV and DHBV) and non-
enveloped (Bluetongue virus), RNA genome (HIV and BVDV) and DNA genome 
(DHBV), and single stranded (HIV) and double stranded (DHBV) genomes. The 
bacteria evaluated represent Gram negative bacilli (Yersinia sp., Serratia sp., E. coli, 
Salmonella sp. and Pseudomonas sp.) and Gram positive cocci (S. epidermidis and 
S. aureus) that are significant especially for RBC transfusion. The protozoan 
parasites evaluated to date are Plasmodium falciparum and Babesia microti. 
INTERCEPT RBCs have demonstrated adequate viability in terms of in vivo 
recovery and lifespan for transfusion (Cancelas 2015), and a recently completed 
Phase 3 clinical study (CLI 00076) in cardiovascular surgery patients conducted in 
Europe has demonstrated that INTERCEPT RBCs possess in vitro characteristics 
comparable to untreated RBCs with a comparable safety profile (Brixner 2015, Rico 
2015). 
The proposed phase 3 study in patients undergoing complex cardiac surgery is 
intended to demonstrate that INTERCEPT RBCs are non-inferior to conventional 
RBCs with regard to clinical safety and clinical efficacy for transfusion support of 
acute anemia during surgery with potential hemodynamic instability. The study is 
designed to support the licensure of the INTERCEPT Blood System for Red Blood 
Cells. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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NAME AND DESCRIPTION OF THE INVESTIGATIONAL 
PRODUCT 
The INTERCEPT Blood System for RBCs is an investigational medical device used 
to prepare pathogen and leukocyte inactivated RBC components for transfusion.    
2.2.1 
Description of Investigational Product 
The investigational device is the INTERCEPT Blood System for Red Blood Cells.  
The pathogen reduction process begins with a unit of RBCs derived from whole 
blood that is separated according to local regulations and standard operating 
procedures at the Blood Centers. RBCs are suspended in additive solution-5 (AS-5). 
Leukocyte-reduction of whole blood or RBCs will be performed per manufacturer’s 
instructions. The INTERCEPT Blood System process is performed on a single unit 
of leukoreduced RBC in AS-5.  
For a detailed description of the investigational product, please refer to the 
Investigator’s Brochure. 
 
SUMMARY OF NONCLINICAL AND CLINICAL STUDIES 
The INTERCEPT treatment process uses amustaline and glutathione together with a 
processing solution in a single-use disposable set to produce pathogen inactivated 
RBCs in SAG-M additive solution.  Cerus’ pre-clinical and clinical development 
program has evaluated the efficacy of amustaline for pathogen inactivation and 
safety profiles of treated RBCs and breakdown products with regard to systemic 
toxicity, genotoxicity and carcinogenicity in accordance with International Council 
on Harmonization (ICH) standards for RBCs development of pharmaceuticals. 
These data are presented in detail in the Investigator’s Brochure. 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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2.3.1 
Safety 
No physiologically relevant toxicity using INTERCEPT RBCs at doses higher than 
planned for this trial was observed in pre-clinical studies. Additional information 
about the toxicological evaluations of the treatment system is provided in detail in 
the Investigator’s Brochure.  
2.3.2 
Immunogenicity 
The mechanism of action of S-303 can also lead to reactions with macromolecules 
other than nucleic acids in the blood components, such as constituents of the red cell 
membrane. In early studies of the pathogen inactivation process for RBCs (referred 
to as “Original process”) there was evidence of antibody formation directed against 
INTERCEPT RBCs (also referred to as S-303-specific RBC antibodies) in two 
patients participating in a chronic RBC transfusion study.  In order to minimize 
these non-specific and unwanted reactions with RBC surface molecules, an 
increased level of the quencher, glutathione (GSH), has been included in the current, 
pathogen inactivation process (referred to as “Current process”).  
Additional information regarding the potential for immunogenicity, and the studies 
that have been conducted is provided in the Investigator’s Brochure. 
2.3.3 
Clinical Studies 
Four clinical studies have been completed with the current process of the 
INTERCEPT Blood System for RBCs. The studies are summarized in Table 2.1 
below and additional detail is provided in the Investigator’s Brochure.  
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT 
Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Table 2.1 Summary of Clinical Studies with INTERCEPT Blood System for RBCs Current Process 
Study ID 
Number 
of Study 
Centers 
Design 
Study & Ctrl 
Drugs (Dose, 
route & 
regimen) 
Study 
Objective 
# subjects 
(entered, 
completed) 
Diagnosis 
Primary 
Endpoint(s) 
Main Findings 
CLI00062 
(RBC08001) 
2 
Randomized, 
single blinded, 
controlled, 2 
period, cross-
over 
Single 
transfusion of 
5-15 mL of 51Cr-
labeled Test 
(S-303) or 
Control RBCs 
(35 day storage), 
intravenous 
Recovery of 
IBS treated 
autologous 
RBCs; safety 
and 
tolerability 
26/26 
Healthy adult 
subjects 
24 hour recovery 
and life span of 35 
day old autologous 
RBCs 
IBS-treated RBCs met FDA 
recommended criteria for 24 hour 
recovery with no significant difference 
between IBS-treated and control RBC 
Survival was significantly different 
between Test (32.8 days) and Control 
(39.5 days) but T50 of Test was within 
published reference range (28-35 days)  
No physiologically meaningful 
differences at end of storage between 
Test and Control RBC 
CLI00073 
 
Single-blinded, 
randomized 
crossover 
Single 
transfusion 
µ10-30 mL of 
51Cr-labeled 
Test (S-303) or 
Control RBCs 
(35 day storage), 
intravenous 
Compare 
survival and 
recovery of 
autologous 
S 303 RBCs 
to 
conventional 
RBCs 
42 enrolled/ 
26 completed 
Healthy 
subjects 
24 hour post-
infusion dual label 
recovery of 
autologous RBCs 
stored for 35 days 
The 24-hour post-transfusion recovery 
(both dual- and single-label) of 
autologous IBS RBCs following 
infusion after 35-days of storage met all 
the FDA criteria for the evaluation of 
RBC products. 
No immunologic reactivity developed to 
Test RBC. 
CLI00070 
3 
Randomized, 
controlled, 
double blinded, 
parallel  
IBS treated or 
untreated RBC 
transfusions for 
up to 7 days 
starting on day 
of surgery; dose 
and frequency 
per treating 
physician 
In vitro 
characterizati
on of IBS 
RBCs relative 
to EU criteria 
for RBC for 
transfusion  
Obtain 
clinical data 
to support 
design of 
add’l studies 
87 
randomized; 
51 treated 
(25Test, 
26Control) 
Patients 
undergoing 
complex 
cardiac 
surgery with 
high 
likelihood of 
requiring 
RBC 
transfusion 
Primary in vitro 
endpoint Hb 
content/unit 
 
Primary clinical 
endpoint  = safety 
 
Exploratory 
endpoints indicative 
of tissue 
oxygenation 
include renal or 
IBS RBC demonstrated equivalence to 
untreated RBC regarding hemoglobin 
content; the proportion of IBS RBCs 
satisfying the EDQM guidelines was 
higher than for conventional RBCs.   
 
The incidence of renal insufficiency was 
15.7% (Test 5, Control 3, p=0.41). The 
incidence of hepatic insufficiency was 
2% (Test 1, Control 0, p=0.37). There 
was no statistical difference between 
Test and Control groups for the 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT 
Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Study ID 
Number 
of Study 
Centers 
Design 
Study & Ctrl 
Drugs (Dose, 
route & 
regimen) 
Study 
Objective 
# subjects 
(entered, 
completed) 
Diagnosis 
Primary 
Endpoint(s) 
Main Findings 
to support 
registration of 
IBS for RBC 
hepatic 
insufficiency and 
6MWT 
assessments of the 6MWT at the time of 
first ambulation post-surgery and at day 
13 or discharge.  
 
No statistical differences in the overall 
incidence of AE rates, or in possibly 
related AEs between Test and Control, 
with similar distribution of SAEs 
between groups. The events observed 
were those expected in this population. 
CLI 00076 
3 
Randomized, 
controlled, 
double blinded, 
two-period, 
crossover, non-
inferiority 
Six transfusion 
episodes of Test 
(INTERCEPT) 
or Control RBC; 
each treatment 
period to include 
2 wash-in 
episodes and 4 
study transfusion 
episodes; 
subjects will be 
transfused to 
maintain the 
same target 
hemoglobin 
level specified 
by treating 
physician in 
each study 
period 
Evaluate the 
efficacy and 
safety of 
INTERCEPT 
RBCs in 
subjects who 
require 
chronic 
transfusion 
support due to 
thalassemia 
major 
86 
randomized, 
81 treated 
Subjects with 
thalassemia 
major who 
require 
chronic 
transfusion of 
RBC 
components 
Hgb consumption 
during each 
efficacy evaluation 
period (episodes 4 
to 6) measured as 
the Hgb mass 
transfused per 
subject adjusted for 
episode-specific 
body weight and 
duration (Hgb g/kg 
body weight/day). 
Incidence of a 
treatment-emergent 
antibody with 
confirmed 
specificity to 
INTERCEPT 
treated RBCs 
associated with 
clinically 
significant 
hemolysis 
The non-inferiority of INTERCEPT 
RBC components for the primary 
efficacy endpoint was robustly achieved 
consistently for both the ITT and PP 
analysis groups. No treatment emergent 
antibodies to INTERCEPT RBC were 
detected. 
Adverse events were equally distributed 
between Test and Control periods. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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SUMMARY OF POTENTIAL RISKS  
The potential risks of this study include those adverse reactions that are recognized to 
occur following any transfusion of RBC components and could be anticipated to 
occur with either control or INTERCEPT-treated components including, but not 
limited to, delayed serologic transfusion reactions (DSTRs), acute hemolytic 
transfusion reactions (AHTRs), delayed hemolytic transfusion reactions (DHTRs), 
febrile non-hemolytic transfusion reactions (FNHTRs), allergic (urticarial) reactions, 
anaphylaxis, transfusion-related acute lung injury (TRALI), transfusion-associated 
circulatory overload (TACO), transfusion-related sepsis (TRS), or transfer of an 
infectious agent via transfusion/transfusion transmitted infection (TTI), respectively, 
transfusion- associated graft-vs-host disease (TA-GVHD), and allo-immunization to 
RBC and HLA antigens.  
The development of antibodies to INTERCEPT RBCs, or to neoantigens formed as a 
result of acridine binding to red cells, could occur as a result of transfusion with 
INTERCEPT RBCs. Acridine-specific antibodies were observed in an early and 
current ongoing blinded studies (as described in the Investigator’s Brochure) and 
many could be neutralized with acridine in solution, thereby defining specificity for 
this moiety. The occurrence of these antibodies was not associated with any clinical 
events or observations. The Current process has been optimized to decrease the 
likelihood of this event.  
A screening study was performed to evaluate the prevalence of natural antibodies 
with specificity for INTERCEPT RBCs (SUD 00742). Five plasma samples from 998 
subjects requiring chronic transfusion support for anemia and 12 plasma samples 
from 10,721 hospital subjects demonstrated low titer cross-reactions with 
INTERCEPT RBCs.  The cumulative prevalence of cross-reactive antibodies to 
INTERCEPT RBCs was 0.15%.  Each of the antibodies identified was characterized 
and none were found to be IgG1 or IgG3 subclass, the antibody subclasses most 
associated with physiologic hemolytic activity.  The majority demonstrated 
specificity for acridine.   
Several instances of treatment emergent antibodies with specificity for INTERCEPT 
RBCs were reported during the ongoing Phase III clinical investigations. In each 
event, the antibodies were shown to be non-clinically significant without evidence of 
patient harm. These studies remain blinded and it is not known whether the patients 
received Test of Control RBCs. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Natural antibodies to INTERCEPT RBCs are expected to occur in ongoing clinical 
trials. Risk mitigation is in place to protect patients and further evaluate clinical 
significance. All study subjects are screened before enrollment for INTERCEPT 
RBC-specific antibodies and subjects with natural cross-reactive antibodies are 
excluded. Subjects are regularly screened during the study including at approximately 
75 days after the last study RBC transfusion in all ongoing clinical trials. Subjects 
with treatment emergent antibodies are withdrawn from receiving study RBC and are 
fully evaluated for evidence of hemolysis. Stopping rules are in place related to the 
occurrence of delayed serological and hemolytic TRs associated with treatment 
emergent antibodies to INTERCEPT RBCs.  
Additional risks associated with Control components, that INTERCEPT treatment is 
designed to reduce, include risk of infectious contamination by viral or protozoan 
agents, such as HIV, HCV, HBV, malaria, and emerging viruses such as Zika, 
Dengue and Chikungunya. 
The risk of bacterial contamination is considered to be negligible with INTERCEPT 
RBC components and, although it has not been measured directly, is expected to be 
less than the risk of bacterial contamination with conventional RBC components, thus 
providing a potential benefit of receiving INTERCEPT-treated components. 
Finally, human error, clerical error and transfusion of RBC to the wrong patient 
remain risks of red cell transfusion. 
 
DESCRIPTION OF AND RATIONALE FOR TREATMENT 
Patients undergoing cardiac surgery are an appropriate study population because (i) 
these patients commonly require multiple RBC transfusions for support of acute 
anemia and might be expected to manifest complications ascribed to exposure to 
allogeneic blood, (ii) cardiac surgery patients comprise a large group of recipients 
with acute anemia requiring RBC transfusion and on a national basis account for a 
significant proportion of blood component utilization, and (iii) following 
cardiopulmonary bypass surgery, patients are in a pro-inflammatory state which 
might make them particularly vulnerable to adverse consequences of RBC 
transfusion, especially decreased  tissue and organ oxygenation. While other types of 
surgical patients receive blood for acute anemia, they are either difficult to study in a 
clinical trial setting (e.g., trauma patients) or they may have high rates of autologous 
blood transfusion use (e.g., orthopedic patients). Cardiac surgery is also one setting 
where a liberal RBC transfusion policy has been documented to increase overall 
survival, suggesting an important role in ensuring tissue oxygenation (Murphy 2015). 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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The acute nature of the transfusion support in the setting of surgical blood loss with 
many confounding variables unrelated to the properties of RBC components limits 
the utility of measuring post-transfusion hemoglobin increments, and other direct 
measures of therapeutic benefit (Weiskopf 1998). In addition, evaluation of RBC 
component therapeutic efficacy is challenging because no single endpoint adequately 
reflects RBC transfusion efficacy in acute anemia. However, a reasonable approach is 
to assess a single key organ system such as renal as the primary endpoint.  
Accordingly, the primary efficacy measure in the proposed study is renal impairment 
defined by changes in serum creatinine .  
Lassnigg et al. (Lassnigg 2004, Lassnigg 2008) found that measuring repeat sCr 
concentrations within 48 hours of cardiothoracic surgery and determining the ∆sCr 
from pre-surgery baseline concentrations was the most effective discrimination 
method to find patients at risk for adverse postoperative outcomes, including 
mortality by Day 30 post-surgery. In independent studies at two different European 
institutions that incorporated all cardiac surgery patients who survived at least 48 
hours post-surgery, they found that ∆sCr concentrations declined in the majority of 
patients and was associated with the lowest mortality (1.8%). Minimal increases [0-
0.5 mg/dL were associated with a more than doubled mortality in both centers 
(5%/6%).  Used as a sole criterion, ∆sCr within 48 hours of surgery was more 
sensitive than the RIFLE (Mehta 2007) and AKIN (Bellomo 2004) definitions of 
Acute Kidney Injury (AKI) as a correlate of poor outcomes. The most important 
findings of these studies were that 1) even a small absolute increase in sCr in the post-
cardiac surgery setting confers an adverse prognosis and increases the risk of death; 
2) a window of 48 hours following cardiac surgery was able to classify the risk 
groups; and 3) ease of use and early prediction ability of absolute sCr changes alone 
challenge the RIFLE and AKIN classifications in these patients.  
Historically acute kidney injury (AKI) is known to complicate recovery from cardiac 
surgery in up to 30% of patients, and places patients at a 5-fold increased risk of 
death during hospitalization (O'Neal et al. 2016).  
AKI has been validated as a predictor of adverse outcomes after cardiac surgery 
based on sCr assessment alone. Many analyses do not incorporate urinary output 
(UO) as a component of the AKI measure, especially in cardiac surgery patients. For 
example:  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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• 
Hobson et al. (Hobson 2009) describe 2973 cardiac surgery patients between 
1992 and 2002 and define AKI as a ≥50% increase in sCr from pre-surgery 
baseline. Survival was worse among patients with AKI and was proportional to 
its severity, with an adjusted hazard ratio of 1.23 (95% CI 1.06 to 1.42). 
• 
Loef et al. (Loef 2005) describe an association of in-hospital and long term 
mortality with post-operative sCr levels only, in 843 cardiac surgery patients in 
1991 (hazard ratio of death 1.83;95% confidence interval 1.38 to 3.20). 
• 
More recently, Zhou et al. (Zhou 2016) confirmed the association of AKI based 
only on sCr criteria, with higher mortality and longer length of stay in 1036 
critically ill ICU patients. 
AKI that requires renal replacement therapy occurs in 2–5 % of patients following 
cardiac surgery and is associated with 50 % mortality (O'Neal 2016). For those who 
recover from renal replacement therapy or even mild AKI, progression to chronic 
kidney disease in the ensuing months and years is more likely than for those who do 
not develop AKI. Renal ischemia, reperfusion, inflammation, hemolysis, oxidative 
stress, cholesterol emboli, and toxins are known to contribute to the development and 
progression of AKI. Transfusion with RBC may prevent AKI by ensuring tissue 
oxygenation during and after surgery, but is also hypothesized to exacerbate AKI by 
the release of non-transferrin bound iron, promotion of a pro-inflammatory state, 
impairment of tissue oxygen delivery, and exacerbation of tissue oxidative stress 
(Karkouti 2012). A comparison of AKI incidence using conventional and 
INTERCEPT-treated RBC in cardiac surgery therefore offers a sensitive predictive 
measure of the equivalence of long-term outcomes following acute RBC transfusion 
for both benefits and potential harms. 
Lassnigg et al. (Lassnigg 2004, Lassnigg 2008) found an association of small changes 
in serum creatinine (∆sCr) in the first 48 hours after surgery with mortality by day 30, 
and an independent association of transfusion with adverse outcomes. In the ReCePI 
study we will enroll cardiac patients that are likely to require RBC transfusions using 
the Transfusion Risk Understanding Screening Tool (TRUST) Score (Alghamdi 
2006), and these patients are more likely to suffer post-surgery renal impairment than 
patients who are less likely to require transfusion.  
Cerus has completed two studies in cardiac surgery in patient populations similar to 
that proposed in ReCePI, and these data have been submitted to the FDA: RBC3A01, 
“S-303 Treated Red Blood Cell Use in Patients Requiring Acute Transfusion 
Support,”(Benjamin et al. 2005) (submitted  to the FDA on March 30, 2005 under 
IDE 7750/91) and CLI 00070, “A Randomized Controlled Double-Blind Phase 3 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Study to Assess Characteristics of S-303 Treated RBC Components and Evaluate 
Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia,” 
(submitted to the FDA on 30 September 2016 [Reference IDE 13803/65]).  
The above studies inform the selection of the proportion of patients that are likely to 
meet the criterion of raised ∆sCr within 48 hours post the completion of cardiac 
surgery. A summary table (Table 2.2) provides the data from our analysis of studies 
RBC 3A01 and CLI 00070 that shows that the proportions of Control patients had 
∆sCr values within 48 hours of surgery completion as follows: ≥0.1mg/dL = 55%; 
≥0.2 mg/dL = 45%; and ≥0.3 mg/dL = 30%. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT 
Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Table 2.2 Reanalysis of Cerus Studies RBC 3A01 and CLI 00070 Using Renal Impairment Based on Change in Serum 
Creatinine Levels within 48 hours of Cardiac Surgery 
 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Based on these data, Cerus proposed a non-inferiority design in ReCePI to rule out an 
increase of ∆sCr ≥0.3mg/dL more than 50% from the Control rate with approximately 
80% power and one-sided alpha of 2.5%. This is based on a Control rate of ∆sCr 
≥0.3 mg/dL of 30%.  At least 292 subjects will be randomized and transfused. 
Randomization (in 1:1 ratio for Test:Control) stratified by site, pre-existing renal 
impairment (stratum with either sCr ≥1.2mg/dL or sCr<1.2 mg/dL at baseline), and 
cardiac surgery risk level (high or low risk stratum group 1 or 2, respectively) will be 
employed.  
As per Lassnigg et al (2004 and 2008) patients who die within 48 hours of the end of 
surgery and have received at least one study transfusion will be included in the 
modified intent-to-treat (mITT) analysis but excluded from the per protocol analysis. 
Patients who have not received a study transfusion within 48 hours of surgery will be 
excluded from the analysis and replaced. 
Additional endpoints will include mortality or the need for RRT (defined as 
hemodialysis or peritoneal dialysis) by Day 30 post-surgery; and AKI as defined by 
modified Kidney Disease Improving Global Outcomes (KDIGO) criteria. Any RRT 
that is provided prophylactically during surgery while patient is on a bypass machine 
does not meet this endpoint. The vital status and RRT assessment on Day 30 after 
surgery can be performed either from the medical records, from a phone call to the 
subject or family, or during the visit 28 +/- 3 days after the last study transfusion if 
the window covers 30 days after surgery time point. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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3 
STUDY OBJECTIVES 
The objective of this study is to evaluate the efficacy and safety of RBC transfusion 
for support of acute anemia in cardiovascular surgery patients based on the clinical 
outcome of renal impairment following transfusion of RBCs treated with the 
INTERCEPT Blood System for Red Blood Cells compared to patients transfused 
with conventional RBCs. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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4 
INVESTIGATIONAL PLAN 
 
ENDPOINTS 
4.1.1 
Primary Endpoints 
The primary efficacy endpoint is the proportion of patients, who have received at 
least one study transfusion with a diagnosis of renal impairment defined as: 
• 
Any raised sCr level, occurring after transfusion of a study RBC, of ≥0.3 mg/dL 
(or 26.5 µmol/L) from the pre-surgery baseline within 48±4 hours of the end of 
surgery. 
If any subject meets this criterion before receiving a study transfusion, that particular 
event will not be included in the primary endpoint analysis. The treatment 
comparison for the primary efficacy endpoint will be assessed by a non-inferiority 
test (Test−Control) with a non-inferiority margin of 50% increase from the Control 
rate and two-sided 0.05 alpha level. Patients who receive a study transfusion but die 
within 48 hours after surgery will be included in the mITT analysis but excluded from 
the per protocol analysis. 
The primary safety endpoints are: 
• 
Proportion of patients with any treatment-emergent adverse events (TEAEs) 
possibly, probably or definitely related to study RBC transfusion through 
28 days after the last study transfusion; and  
• 
Proportion of patients with treatment-emergent antibodies with confirmed 
specificity to INTERCEPT RBCs by end of study (i.e., 75±15 days after the last 
study transfusion). 
TEAEs by definition will comprise all untoward medical events occurring after the 
start of the first study RBC transfusion and during the study (i.e., adverse events, 
serious adverse events, unanticipated adverse device effects, TRs and within 28 days 
post last study RBC transfusion). The primary safety endpoint is focused on possibly, 
probably or definitely related adverse events to the study RBC transfusion, because 
these patients have many adverse events which are unrelated to study RBC 
transfusion. 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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4.1.2 
Secondary Endpoints 
• 
Efficacy: Secondary efficacy endpoints include:  
o The proportion of patients with a diagnosis of stage I, II or III Acute Kidney 
Injury (KDIGO 2012) based on changes in sCr levels from pre-surgery 
baseline and the need for renal replacement therapy (RRT) post-surgery.  
o Mortality or the need for RRT by 30 days post completion of surgery. 
Safety: Assessment of additional safety parameters in post-surgical subjects 
transfused with INTERCEPT RBCs compared with subjects transfused with 
conventional RBCs, include: 
• 
Treatment-emergent AEs through 28 days after the last study transfusion. 
• 
Treatment-emergent SAEs through 28 days after the last study transfusion. 
• 
Transfusion reactions (as defined by the CDC National Healthcare Safety 
Network [NHSN] Hemovigilance Module protocol) through 28 days after last 
study transfusion. 
• 
Treatment-emergent immunization to RBC allo-antigens through 28 ±3 days 
after the last study transfusion.  
• 
Treatment-emergent immunization to HLA allo-antigens through 28±3 days 
after the last study transfusion. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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STUDY DESIGN  
The study is a prospective, multicenter, randomized, double-blinded, active 
controlled, parallel-design, non-inferiority study. Figure 4.1 shows the study design 
and Figure 4.2 shows the clinical study flowchart. 
Figure 4.1 Study Design Schematic 
 
(1) Primary efficacy endpoint ∆sCr ≥0.3 mg/dL from baseline assessed within 48±4 hours of the end of 
surgery.  
(2) Secondary efficacy endpoint of mortality or need for RRT assessed on Day 30 post-surgery 
 
 
Control 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Figure 4.2 Study Flowchart 
 
 
 
      
 
 
Find and approach cardiac surgery patients 
age > 11 
Consent/obtain assent  
Assess eligibility  
Assess baseline sCr 
Study measurements until  
post-operative Day 7, 
discharge,  
or death, whichever is first 
Up to 7 calendar days prior to surgery or day of surgery but prior to onset of 
surgery, confirm Test and Control units are available and randomize subject. 
Document baseline sCr 
S-303 Antibody Screen negative non-reactive 
Received INTERCEPT or  
Conventional RBC transfusion  
(target ≥292 evaluable subjects) 
No Study RBC after randomization 
through 48 hours after completion 
of surgery 
Safety monitoring (TRs, AEs, SAEs through 28 days after the  
last study transfusion. Documentation of vital status and RRT  
on Day 30 post surgery, sCr, DAT/IAT and screen for  
antibodies specific to INTERCEPT RBCs and HLA  
antibodies at 28±3 days after the last study transfusion) 
Documentation of vital status, need for RRT, blood 
samples for antibodies specific to INTERCEPT RBCs  
on 75+15 days after the last study transfusion 
End study 48 hours after surgery 
and replace study subject  
Adverse events (AEs) will not 
be collected for non-transfused 
subjects 
Vital status will be reported for 
randomized and non-transfused 
subjects at the time of 
discontinuation.Daily sCr 
assessments will be recorded up 
to and including 48 ±4 hours post 
surgery. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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RANDOMIZATION AND BLINDING 
Potentially eligible subjects will be screened and will be considered for 
randomization.  If a subject is screened and receives a RBC transfusion prior to 
randomization, that subject will no longer be considered for randomization, and their 
participation in the study will end. Patients may be rescreened for eligibility closer to 
the time of surgery. An Interactive Web Response System (IWRS) will be used for 
electronic randomization of eligible patients. Following screening and prior to 
surgery (up to 7 days before surgery or day of surgery but before start of surgical 
procedure), the subject’s eligibility status will be re-checked and entered in the eCRF. 
If eligible, the subject will be randomized with a 1:1 ratio for Test:Control within 
his/her randomization stratum.  Randomization will be stratified by site, pre-existing 
renal impairment (sCr ≥1.2 mg/dL vs. < 1.2 mg/dL), and surgery group based on less 
(# 1-3 below) vs. more (#4-7 below) risk for renal complications (based on Mehta 
2006 and expert opinion).  
Less Risk  
1. 
Single Vessel Coronary Artery Bypass Graft, first or repeat procedure 
2. 
Multiple Coronary Artery Bypass Grafts, first or repeat procedure 
3. 
Single Valve Repair or Replacement, first or repeat procedure 
More Risk  
4. 
Multiple Valve Repair or Replacement, first or repeat procedure 
5. 
Surgery involving both Coronary Artery Bypass Graft(s) and Valve 
Repair(s), first or repeat procedure 
6. 
One or more of the following procedures, with or without Coronary 
Bypass Graft(s): 
• 
Left ventricular aneurysm repair, 
• 
Ventricular and/or atrial septal defect repairs,  
• 
Batista procedure (surgical ventricular remodeling),  
• 
Surgical ventricular restoration,  
• 
Congenital cardiac defect repair, 
• 
Aortic procedures, 
7.  
Other complex cardiac surgery or thoracic aorta surgery procedures not 
listed above 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Patients undergoing urgent or emergent cardiac surgery are eligible for the study, 
subject to institutional review board (IRB) approval of an appropriate informed 
consent process. 
Randomized subjects who do not receive any study RBC transfusions within the first 48 hours 
after completion of surgery will be discontinued from study and replaced. Serum Creatinine 
up to and including 48 ±4 hours post-surgery will be collected. 
Other post baseline laboratory parameters and Adverse events (AEs) will not be collected for 
non-transfused subjects. Vital status will be reported for randomized and non-transfused 
subjects at the time of discontinuation.  
Only appropriate blood bank staff and unblinded delegates who monitor the production of the 
RBC components will be able to access the treatment arm assignment.  Selected Blood Center 
staff will not be blinded due to their role required for collection, preparation, and releasing of 
Test and Control RBC components for transfusion to study subjects. An unblinded study 
monitor will review and verify source data collected at the blood banks. Operating room staff, 
surgical staff, ICU staff and others caring for participating patients, as well as the sponsor (and 
delegates) will be blinded to treatment assignment.  Study RBC components will be labeled in 
a manner to maintain the blind. In order to protect the blind, on the day of planned transfusion, 
the final product (test and control) will be transferred by the Blood Bank unblinded personnel 
into a commercially available RBC storage container (Fenwal™ Transfer Pack™ Container – 
600mL, product code 4R2023) using a sterile docking technique.  Blood transferred into an 
ancillary container should be stored at 1oC to 6oC and transfused within 7 days of transfer.   
 
TREATMENT 
Eligible subjects will be consented/provide assent and randomized to receive either 
INTERCEPT RBCs (Test) or conventional RBCs (Control) which will be transfused 
as needed starting from surgery at Day 0 until study post-operative Day 7, hospital 
discharge or death, whichever is first.  
Treatment assessments will be divided into an acute transfusion support period 
starting on the day of surgery (Day 0) until post-operative Day 7, hospital discharge, 
or death, whichever is first, and a post-surgical follow-up visit (28±3 days) after the 
last study transfusion to collect additional safety data. A sample for sCr determination 
will be taken at 48±4 hours after the end of surgery to document the primary efficacy 
endpoint.  For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 
hours post-surgery.  Patient status with regard to mortality and RRT on Day 30 post 
surgery will be documented. Anesthesia and surgical procedures will be performed 
according to the local standards of the institution.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Study RBC components will be ordered and administered to study subjects by 
treating physicians, according to the local standards of care. Following the 
post-surgery 7-day acute transfusion support period, subjects will receive 
conventional RBC components if additional transfusions are needed, as indicated by 
their treating physician. 
4.4.1 
Test Product 
The INTERCEPT treatment will be performed on leukoreduced RBC components 
prepared from citrate phosphate dextrose (CPD) anticoagulated whole blood and 
suspended in AS-5 additive solution (input) within 24 hours of collection.  The test 
component is allogeneic INTERCEPT treated RBC components prepared following 
the Instructions for Use for the INTECEPT Blood System for RBCs (SPC-EN 00581-
AW) and stored in SAG-M at 1°C to 6°C for up to 35 days post-donation and 
administered intravenously.  Test RBC components will be released to clinical 
inventory after review of the batch production record associated with the 
INTERCEPT treatment process.  
4.4.2 
Control (reference) Product 
The Control transfusion component is CPD or citrate phosphate double dextrose 
(CP2D) anticoagulated whole blood derived conventional leukoreduced RBC 
components suspended in an FDA approved additive solution (e.g., AS-1, AS-3 or 
AS-5) and stored at 1°C to 6°C for up to 35 days post-donation and administered 
intravenously. The Control RBC components will be handled and labeled in a manner 
to maintain blinding. Control RBC components will be released to clinical inventory 
after review of the batch production record associated with the trial. 
 
SUBJECT DISCONTINUATION  
The following groups of subjects will not be eligible for study enrollment or will be 
discontinued from the study and may be replaced.   
• 
Screened subjects who receive an RBC transfusion before undergoing 
randomization will not be eligible for study enrollment. 
• 
Screened subjects who are not randomized before their surgery begins will not 
be eligible for enrollment. 
• 
Randomized subjects who do not undergo surgery within 7 days of 
randomization, will be discontinued 7 days after randomization. Patients may be 
re-screened for eligibility and randomization closer to the time of surgery. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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Randomized subjects who do not receive a study RBC transfusion within the first 48 
±4 hours after surgery will be discontinued and replaced and will not be followed any 
longer.  For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 
hours. Daily sCr assessments will be recorded up to and including 48 ±4 hours post 
surgery. Other post baseline laboratory parameters and Adverse events (AEs) will not 
be collected for non-transfused subjects. Vital status will be recorded at the time of 
discontinuation.  
• 
Enrollment Pause and Stopping Rules  
4.5.1 
Definitions 
4.5.1.1 Enrollment Pause 
“Enrollment Pause” means that new patients will not be consented or provide assent 
for the study and subjects already screened will not be randomized.  Subjects already 
randomized and receiving study RBC transfusions will continue to receive study 
transfusions with IAT crossmatch with each RBC component and a new screen for 
antibodies specific to INTERCEPT RBCs every third day to optimize protection of 
enrolled recipients. The FDA will be notified of all DSTRs specific to INTERCEPT 
RBCs. 
4.5.1.2 Clinical Stop 
“Clinical Stop” means complete cessation of recruitment activities and all study 
transfusions, thus stopping the active study transfusion phase of the study. Study 
participants will continue receiving non-study conventional transfusions as needed. 
All safety monitoring tasks will continue as per protocol. 
4.5.1.3 Rules 
The study may be temporarily paused or definitively stopped based on, but not limited 
to, the following rules/considerations: 
• 
Poor/slow accrual: The goal is to recruit at least 292 patients in the study. The 
study may be stopped by the Sponsor if enrollment rates are not deemed 
acceptable or financially sustainable. 
• 
Safety 
• 
The DSMB will review safety data and make recommendations as per the 
current version of the DSMB Charter including interpretation of the stopping 
rules.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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• 
The major safety concern in this trial is the possible development of antibodies 
specific to INTERCEPT RBCs that causes accelerated RBC clearance, as 
evidence of an acute or delayed hemolytic transfusion reaction (AHTR or 
DHTR). The study will be stopped if one subject who has been exposed to 
INTERCEPT RBC demonstrates a confirmed antibody with specificity to 
INTERCEPT RBCs and experiences a clinically significant HTR with overt 
intravascular or extravascular hemolysis as assessed by the Investigator and 
reviewed by the DSMB.   
Stopping rules due to the occurrence of INTERCEPT RBC-specific DSTRs, DHTRs, 
AHTRs or hyperhemolysis syndrome are followed after discussion with Sponsor in 
the event of a positive antibody specific for INTERCEPT RBCs. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Table 4.1 Stopping Rules for INTERCEPT RBC-specific antibodies 
 
Trigger 
Sponsor 
Action 
Notify 
Enrollment 
On 
Study 
Patients 
Continuation 
Additional actions 
 
For INTERCEPT 
RBC- Specific Abs 
 
IRB 
FDA 
DSMB 
 
- 
1 
INTERCEPT RBC-
Specific DSTR with 
no evidence of 
hemolysis  
Patient 
Withdrawal  
X 
X 
X 
Continue  
Continue1  - 
Sponsor will notify DSMB 
and FDA of each 
INTERCEPT RBC-Specific 
Ab2. Investigation may 
include unblinding the 
treatment assignment  
2 
INTERCEPT RBC- 
Specific DHTR (x1)  
Clinical 
Stop  
X 
X 
X 
Stop  
Stop  
After 
Investigation 
& discussion 
with FDA & 
DSMB  
Investigate full hemolytic 
potential.  
Continuation contingent on 
outcome of investigation, 
including confirmation that 
the subject has been 
exposed to INTERCEPT 
(Test) RBCs, and on FDA 
agreement on resumption. 
3 
INTERCEPT RBC- 
Specific AHTR (x1)  
Clinical 
Stop  
X 
X 
X 
Stop  
Stop  
After 
Investigation 
& discussion 
with FDA & 
DSMB  
Stop study for an 
INTERCEPT RBC-specific 
single acute  
hemolytic reaction.  
Continuation contingent on 
outcome of investigation, 
including confirmation that 
the subject has been 
exposed to INTERCEPT 
(Test) RBC, and on FDA 
agreement on resumption. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Trigger 
Sponsor 
Action 
Notify 
Enrollment 
On 
Study 
Patients 
Continuation 
Additional actions 
 
For INTERCEPT 
RBC- Specific Abs 
 
IRB 
FDA 
DSMB 
 
- 
4 
INTERCEPT RBC- 
Specific Hyper-
hemolysis Syndrome 
(x1)  
Clinical 
Stop  
X 
X 
X 
Stop  
Stop  
With FDA 
release  
Investigation may include 
unblinding the treatment 
assignment  
1 The DSMB would make a decision on whether or not to pause the study each time a DSTR occurs with INTERCEPT RBC specificity.  
2 Applies to all INTERCEPT RBC-specific antibody examples shown in rows 1-4.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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ACCOUNTABILITY OF STUDY PRODUCT 
The Investigational Product includes both the INTERCEPT Blood System for RBCs, 
a medical device used to prepare pathogen inactivated RBC components for 
transfusion, and the investigational biological product, INTERCEPT RBCs in 
SAG-M. 
The investigational device accountability will be verified by the unblinded study 
monitors throughout the duration of study. They will assure that the device 
components are under control at all times inclusive of shipment, storage, usage, and 
disposition. 
The investigational biologic product will be produced by each Blood Center 
according to the Study RBC Processing Procedures and accountability will be tracked 
using the Blood Center’s electronic data management system.  
Both Test and Control RBC components are for the sole use of study participants. 
They may not be crossed back into general inventory at a blood center or clinical site. 
The disposition of all components prepared for the study (transfused, discarded or 
expired) will be recorded.  The investigational biologic product accountability will be 
verified by the unblinded study monitors throughout the duration of study. 
 
SOURCE DATA 
The subjects’ medical records are the source data; the study data will be recorded in 
an EDC system using eCRFs. Data worksheets used during the preparation of study 
RBC components are considered the source data for processing study RBC 
components.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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5 
SELECTION AND WITHDRAWAL OF SUBJECTS  
 
SUBJECT INCLUSION CRITERIA 
The following conditions must be met before a subject may be randomized into the 
study. 
1. 
Age ≥ 11 years old 
2. 
Weight ≥ 40 kg 
3. 
Scheduled complex cardiac surgery or thoracic aorta surgery. The procedure 
may be performed either on or off cardiopulmonary bypass machine (CPB or 
“pump”). For the purposes of this protocol “Repeat procedure” means that the 
subject had a previous cardiac surgery. Procedures that qualify as complex 
cardiac surgery include but are not limited to the following: 
• 
Single Vessel Coronary Artery Bypass Graft, first or repeat procedure 
• 
Multiple Coronary Artery Bypass Grafts, first or repeat procedure 
• 
Single Valve Repair or Replacement, first or repeat procedure 
• 
Multiple Valve Repair or Replacement, first or repeat procedure 
• 
Surgery involving both Coronary Artery Bypass Graft(s) and Valve Repair(s), 
first or repeat procedure 
• 
One or more of the following procedures, with or without Coronary Bypass 
Graft(s): 
o left ventricular aneurysm repair, 
o ventricular and/or atrial septal defect repairs,  
o Batista procedure (surgical ventricular remodeling),  
o surgical ventricular restoration,  
o congenital cardiac defect repair  
o aortic procedures  
o other cardiac surgery or thoracic aorta surgery types with a high probability of 
bleeding. 
4. 
TRUST probability score (Alghamdi, Davis et al. 2006) ≥ 3, or currently on 
regimen of aspirin (any dose), clopidogrel (or analogs) and/or GPIIb/IIIa 
inhibitors, or at a high probability for need of a transfusion during or after 
surgery at the discretion of  the Investigator. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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5. 
Female subjects of child-bearing potential who meet the 2 criteria below at 
screening: 
• 
A negative urine or serum pregnancy test 
• 
Use at least one method of birth control that results in a low failure rate 
(i.e., less than 1% per year) when used consistently and correctly such 
as implants, injectables, combined oral contraceptives, some 
intrauterine devices (IUDs), sexual abstinence or vasectomized partner. 
6. 
Signed and dated informed consent/assent form. 
 
 
SUBJECT EXCLUSION CRITERIA 
Patients will be excluded from this study if they meet any of the following criteria: 
1. 
Confirmed positive baseline serum/plasma antibody specific to INTERCEPT 
RBCs (S-303 specific antibody) screening panel prior to randomization.  
2. 
Pregnant or breast feeding. 
3. 
Refusal of blood products or other inability to comply with the protocol in the 
opinion of the Investigator or the treating physician. 
4. 
Treatment with any medication that is known to adversely affect RBC viability, 
such as, but not limited to dapsone, levodopa, methyldopa, nitrofurantoin, and 
its derivatives, phenazopyridine and quinidine.  
5. 
Planned cardiac transplantation. 
6. 
Active autoimmune hemolytic anemia.  
7. 
Left ventricular assist device (LVAD) or extracorporeal membrane oxygenation 
(ECMO) support pre-operatively or planned need post-operatively. 
8. 
Cardiogenic shock requiring pre-operative placement of an intra-aortic balloon 
pump (IABP) (NOTE: IABP done for unstable angina or prophylactically for 
low ejection fraction is not excluded). 
9. 
Planned use of autologous or directed donations. 
10. 
RBC transfusion during current hospitalization prior to enrollment and 
randomization (within 7 days). 
11. 
Participation in an interventional clinical study concurrently or within the 
previous 28 days.  This includes investigational blood products, pharmacologic 
agents, imaging materials (including dyes), surgical techniques, or devices.  
Observational studies of FDA cleared or approved products or nutrition, 
psychology, or socioeconomic issues are not grounds for exclusion. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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12. 
Patients with a current diagnosis of either chronic kidney disease or acute 
kidney injury and with sCr ≥1.8 mg/dL at screening and patients requiring 
RRT. (NOTE: If sCr at screening is <1.8 mg/dL, a patient with a diagnosis of 
chronic or acute kidney injury alone is not excluded). 
13. 
Patients with a current diagnosis of either chronic or acute hepatic insufficiency 
and with a total serum bilirubin ≥ 2.0 mg/dL (≥34.2 µmol/L). (NOTE: If total 
serum bilirubin at screening is <2.0 mg/dL, a patient with a diagnosis of chronic 
or acute hepatic failure alone is not excluded). 
14. 
Pre-existing RBC antibody that may make the provision of compatible study 
RBC components difficult. 
15. 
History of TRs requiring washed RBCs, volume reduced RBCs, or RBCs with 
additive solution removed. 
16. 
Patients with documented IgA deficiency or a history of severe allergic 
reactions to blood products. 
17. 
Patients who require gamma-irradiated RBC blood components. 
18. 
Positive DAT as defined below: 
A polyspecific DAT reaction strength > 2+, or 
A polyspecific DAT (any strength) in conjunction with pan-reactivity with a 
commercial IAT antibody screening panel that precludes the identification of 
underlying alloantibodies or indicates the presence of autoantibody. 
 
 
SUBJECT WITHDRAWAL CRITERIA  
Study subjects are free to withdraw consent/assent or discontinue participation in the 
study at any time, without prejudice to further treatment. A patient’s participation in 
the study may be terminated at any time at the discretion of the investigator if he/she 
feels it is in the patient’s best interest.  Randomized subjects who do not receive any 
study RBC transfusions from randomization to within the first 48 hours after surgery 
will be replaced. 
5.3.1 
Discontinuation from study RBC transfusions 
Study RBC transfusions will be discontinued if the subject: 
• 
Becomes pregnant. 
• 
Is treated with a concurrent prescribed medication demonstrated to have caused 
hemolysis while on study. 
• 
Develops an antibody with presumed or documented INTERCEPT RBC 
specificity and cannot be transfused further with INTERCEPT RBCs. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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• 
If INTERCEPT RBC-specific antibodies cannot formally be ruled out, or 
agglutination is visible for all the untreated RBC cells in the panel, (i.e., “pan-
reactive”). 
If the subject is discontinued from study transfusions due to development of 
INTERCEPT RBC-specific antibody after receiving one or more study RBC 
transfusions, the subject should continue on study receiving only non-study RBC 
transfusions if needed and should complete all safety assessments, including the study 
75 ±15 days post last transfusion follow-up visit.  REF 01606 (S-303 Reactive 
Samples: Management of Patients and Samples) should be followed immediately 
after the INTERCEPT RBC-specific antibodies are identified. A specific data entry 
guidance is provided in CRF Completion Guidelines (CCGs) for the INTERCEPT 
RBC-specific antibody reactive test results. 
5.3.2 
Early termination from Study  
Upon early termination from study the tests required of the termination visit will be 
performed. If the subject is terminated from study (for any reason) before transfusion 
of any study RBC product, the subject will be replaced and no further follow up is 
required. For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 
hours.  Daily sCr assessments will be recorded up to and including 48 ±4 hours post 
surgery. Other post baseline laboratory parameters and Adverse events (AEs) will not 
be collected for non-transfused subjects. Vital status will be recorded at the time of 
discontinuation. If the subject has received any study RBC product and it is possible, 
a physical examination, including general neurological examination, should be 
performed, concomitant medications and adverse events should be recorded, standard 
laboratory tests should be collected, and other blood samples should be obtained on 
day 28 ±3 and day 75 ±15 as described in the protocol. 
If consent/assent for further follow-up is withdrawn, the subject should, at minimum, 
be asked to provide a blood sample at the time of withdrawal for sCr, DAT, IAT and 
INTERCEPT RBC-specific antibody screen. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex 
Cardiac Surgery Procedures (the ReCePI study) 
 
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6 
TREATMENT OF SUBJECTS 
 
TREATMENT PLAN 
6.1.1 
Screening/Randomization (Day -30 to Day 0 Pre-Surgery) 
Patients will be identified through pre-operative scheduling procedures in advance of 
their complex cardiac surgery. Patients already hospitalized may be included. 
Patients undergoing urgent or emergent cardiac surgery are eligible for the study, 
subject to institutional review board (IRB) approval of an appropriate informed 
consent process. 
In order to minimize the number of patients who enroll in the study but do not require 
RBC transfusion, only patients with a relatively high likelihood to receive a 
transfusion as determined by the Investigator (e.g., patients currently on regimen of 
aspirin, clopidogrel (or analogs) and/or GPIIb/IIIa inhibitors), or patients with a 
TRUST score of ≥3 will be eligible for enrollment. A TRUST score of ≥3 
corresponds to a high likelihood of requiring red cell transfusion within 96 hours of 
surgery.  Study consent/assent will be sought in these eligible subjects within 30 days 
of their surgical procedure. Subjects who consent/assent to the study will be assigned 
a subject identification (ID) number and undergo screening.  
The complete list of screening assessments are outlined in Table 7.1a. Data may be 
derived from the medical record where performed within 30 days prior to their 
surgical procedure.  Blood samples for determination of HLA antibodies will also be 
collected at the screening visit and sent for testing at a specialty central laboratory.  In 
certain situations, it is possible for a mobile medical professional, authorized by the 
sponsor and requested by site personnel, to conduct a home health service visit at a 
subject’s home to collect screening assessments. Patients who fail eligibility for any 
or multiple inclusion/exclusion criteria may be rescreened for eligibility closer to the 
time of surgery. 
All available components of the TRUST score (age, sex, Hb, weight, type of surgery, 
serum creatinine, surgical history and surgical task) will be collected on the case 
report form.  The TRUST score (or the minimum and maximum possible TRUST 
scores, if there are any missing components) will be calculated according to the 
published algorithm (APPENDIX  1). 
Eligible subjects will be randomized up to 7 days before or on the day of surgery, but prior to 
the start of surgery (i.e., induction of anesthesia). The adverse event collection period will 
begin at the beginning of surgery or the first study RBC transfusion, whichever is first. 

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For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 hours.  Daily sCr 
assessments will be recorded up to and including 48 ±4 hours post surgery. Other post 
baseline laboratory parameters and Adverse events (AEs) will not be collected for non-
transfused subjects.  Vital status will be recorded at the time of discontinuation.  
The complete list of baseline assessments to be performed pre-operatively on the day before 
or on the day of surgery before surgery commences are outlined in Table 7.1b. 
6.1.2 
Acute Transfusion Support Period (Surgery [Day 0] to Post-operative 
Day 7, Hospital Discharge or Death, Whichever is First) 
The complete list of assessments to be performed during the acute transfusion support 
period are outlined in Table 7.1c.  
During the acute transfusion support period (Day 0 to Day 7), hospital discharge or 
death, whichever is first, patients will be transfused with Test or Control RBCs. 
Induction and end of anesthesia are considered start and stop time of surgery. All 
transfusions administered through Day 7 will be of the assigned treatment arm as 
often as feasible without compromising patient care.   
A screen for antibodies specific for INTERCEPT RBCs should be performed every 
time that a routine IAT is performed during the acute 7-day study transfusion period. 
A blood sample for sCr will be taken at 48 (±4 hours) after completion of surgery, 
and sCr will be determined on a daily basis during the acute transfusion support 
period up to 7 days post-surgery. Other parameters will be collected on eCRFs only 
when available in the medical record. 
Randomized subjects who do not receive an RBC transfusion following randomization within 
the first 48 hours after surgery will be discontinued from the study and replaced.  
For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 hours.  
Daily sCr assessments will be recorded up to and including 48 ±4 hours post surgery. 
Other post baseline laboratory parameters and adverse events (AEs)Es) will not be 
collected for non-transfused subjects. Vital status will be recorded at the time of 
discontinuation.  
Once a subject is randomized, in rare exceptions where study RBCs are unavailable 
or a subject’s need for RBC transfusions exceeds the quantities of the prepared study 
RBCs (e.g., during a Massive Transfusion Protocol), non-study RBC (conventional) 
transfusion may be given to provide the subject with an appropriate and necessary 
treatment. Non-study RBC transfusion data is captured in the eCRF. In this case, a 
protocol deviation should be noted. Transfusions will be administered according to 

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local institutional policy and safety standards as ordered by the medical team for 
patient care needs. Anesthesia and surgical procedures will be performed according to 
the local standards of the institution.   
Hemodynamic and laboratory results will be recorded daily from post-surgery 
through post-operative Day 7, hospital discharge or death, whichever occurs first. If 
an assessment is performed more than once in a day, the first set of results should be 
entered into the eCRF. 
If a subject is discharged prior to the end of the acute transfusion support period (Day 
7) but for any reason returns to the study site (e.g., re-hospitalization or standard care) 
within this acute transfusion support period,  lab values routinely collected as 
standard of care should be recorded in the eCRF.  
If multiple assessments (hemodynamic parameters, vital signs, laboratory parameters) 
are taken in a calendar day, the reported value for first collection of the day should be 
recorded in the eCRF with the exception of serum creatinine .  Serum creatinine will 
be collected and recorded in the eCRF on a daily basis during the 7 day acute 
transfusion support period. If serum creatinine is measured multiple times in a day, 
the worst daily value should be recorded in the eCRF.   In addition, a sample to 
measure sCr will be taken at 48±4 hours after the end of surgery and captured on a 
specific CRF page for that time-point. 
For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 hours 
hours post-surgery. Serum Creatinine up to and including 48 ±4 hours post-surgery 
will be collected. 
Urine output (mL/kg/hour) will be recorded in the eCRF daily while a urinary 
catheter is in place.   
Other assessments during this trial period include details related to the specific 
surgical procedure (type of procedure, start and end times, RBC components 
transfused, all other blood components transfused, estimated blood loss from the 
surgical procedure, concomitant medications, intraoperative cell recovery and 
reinfusion, hemodilution, and nadir temperature). Additionally, daily estimated blood 
loss from chest tube(s) and from other sources, and day of chest tube removal will be 
recorded. See Table 7.1c for a detailed list of study assessments. 
AEs and SAEs, including TRs and protocol-specified AEs (see Section 7.3), will be 
assessed from the start of surgery or the start of the first study RBC transfusion 
(whichever is first) on a daily basis and documented in the eCRF through 
post-operative Day 7. Adverse events (AEs) will not be collected for non-transfused 

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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
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subjects, but vital status will be recorded at the time of discontinuation.  See 
Table 7.1c for a detailed list of study assessments. 
NOTE: The following post-operative assessments apply to randomized transfused 
subjects only. 
6.1.3 
Post-operative Period (Day 8 [or Post-discharge, if earlier] through Day 
28 After Last Study Transfusion) 
The complete list of assessments to be performed during this post-operative period 
are outlined in Table 7.1d. 
Laboratory results recorded in the eCRFs during this period will only be those 
assessed as clinically significant per the Investigator. Following the post-surgery 7-
day acute transfusion support period, the post-operative period starts on Day 8 after 
surgery and goes through the Day 28±3 visit. Subjects will receive conventional non-
study RBC components if additional transfusions are needed, as indicated by their 
treating physician. 
Weekly telephone surveillance calls to the subject will be performed to collect AEs, 
SAEs and TRs. If a surveillance call falls on the same week as the Day 28±3 follow-
up visit, the follow-up visit assessments will take precedent and a surveillance call is 
not required. 
6.1.4 
Day 28±3 After Last Study Transfusion or Early Termination 
The complete list of assessments to be performed during the Day 28±3 or Early 
Termination visit are outlined in Table 7.1e.  
Subjects should be scheduled for a follow-up visit 28±3 days after the last study 
transfusion to obtain additional safety information, including subject-reported AEs, 
SAEs, and laboratory results.  This visit may occur either in hospital, clinic visit, or 
offsite. In certain situations, it is possible for a mobile medical professional, 
authorized by the Sponsor and requested by site personnel, to conduct a home health 
service visit at a subject’s home to collect these assessments. Blood samples for 
determination of HLA antibodies will also be collected at the visit and sent for testing 
at a specialty central laboratory.  TRs, AEs and SAEs will be documented for 28 days 
after the last study transfusion, or earlier if the subject dies prior to Day 28 post last 
study RBC transfusion. If a subject has been discharged prior to Day 28 post last 
study RBC transfusion, the vital status, need for RRT and other safety information 
(e.g., AEs and SAEs) may be obtained through medical records, the subject’s 
physician, or a telephone interview with either the subject or a family member.  

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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate 
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6.1.5 
Day 30 – After Surgery Assessment 
The complete list of assessments to be performed at Day 30 are outlined in Table 
7.1e.  
All randomized subjects who receive a study RBC transfusion must have their vital 
status and need for RRT (defined as hemodialysis or peritoneal dialysis) documented 
at Day 30 after surgery. RRT that is provided prophylactically during surgery while 
patient is on a bypass machine (the pump) does not meet this endpoint. The vital 
status and RRT assessment on Day 30 post surgery can be obtained either from the 
medical records, from a phone call to the subject or family, or during the visit 28±3 
days after the last study transfusion (only if the last study transfusion was given at 
day 2 or later in the acute transfusion support period).  
6.1.6 
End of Study (75 ±15 Days After Last Study Transfusion) 
The complete list of assessments to be performed at the 75 ±15 day study visit are 
outlined in Table 7.1e.   
Subjects should be scheduled for a second follow up visit on Day 75±15 days after 
the last study transfusion for vital status, need for RRT, and for assessment of 
INTERCEPT RBC-specific antibodies at end of study, either in hospital, clinic visit 
or off-site. In certain situations, it is possible for a mobile medical professional, 
authorized by the Sponsor and requested by site personnel, to conduct a home health 
service visit at a subject’s home to collect these assessments. If the assessment of 
INTERCEPT RBC-specific antibodies is positive, the positive S-303 specific DSTR 
should be entered on the Adverse Event eCRF. 
6.1.7 
Assessments in Follow-up to a Reactive Antibody Test Specific for 
INTERCEPT RBCs 
In the event of detection of treatment-emergent antibodies with specificity to 
INTERCEPT RBCs, the Investigator shall be instructed about specific laboratory and 
clinical assessments to be performed.  See section 7.3.1.11 Suspected Hemolytic and 
Serologic TRs after Enrollment and Transfusion with Study RBC Components 
assessment of immune reactivity of INTERCEPT for more details.  
 
CONCOMITANT AND EXCLUDED THERAPY 
Standard medical care according to local institutional standards will be provided to 
each subject.  The following concomitant (or planned) therapies/procedures will 
exclude subjects from the current study: 

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• 
Left-ventricular assist device (LVAD) or Extracorporeal membrane oxygenation 
(ECMO) support pre-operatively or planned need post-operatively. 
• 
Cardiogenic shock requiring pre-operative placement of an IABP (Note: IABP 
done for unstable angina or prophylactically for low ejection fraction is not 
excluded). 
• 
Treatment with any medication that is known to adversely affect RBC viability, 
such as but not limited to, dapsone, levodopa, methyldopa, nitrofurantoin, and 
its derivatives, phenazopyridine and quinidine. 
• 
Planned use of autologous or directed donations 
• 
Patients who have received an RBC transfusion during current hospitalization 
prior to randomization (within 7 days) 
• 
Subjects who have received investigational products, including investigational 
blood products, pharmacologic agents or imaging materials, within the prior 28 
days will also be excluded.  
 
TREATMENT COMPLIANCE  
Treatment compliance will be overseen by the Investigator and study staff and 
relevant documentation will be recorded in the eCRF.  Compliance will be monitored 
by the Sponsor and/or Sponsor’s representatives by review of source documents. The 
study RBC components will be labeled and tracked through all stages of processing 
of Test and Control components, storage, issue, and transfusion. 

Cerus Corporation 
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7 
STUDY ASSESSMENTS 
 
STUDY SCHEDULE OF ASSESSMENTS 
A screen for antibodies specific for INTERCEPT RBCs should be performed every 
time that a routine IAT is performed during the acute 7-day study transfusion period. 
A blood sample for sCr will be taken at 48 (±4 hours) after completion of surgery, 
and sCr will be determined on a daily basis during the acute transfusion support 
period up to 7 days post-surgery. Other parameters will be collected on eCRFs only 
when available in the medical record. 
For non-transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 hours and 
daily sCr assessments will be recorded up to and including 48 ±4 hours post surgery. 
All samples obtained for determination of human leukocyte antigen (HLA) will be 
stored for up to 1 year after the study has completed. 
The study assessments used to evaluate both efficacy and safety are presented in 
Table 7.1a, Table 7.1b, Table 7.1c, Table 7.1d, Table 7.1e and 7.2.  
 
 

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Table 7.1a – Screening/Randomization 
Study Period – Screening Visit (Day -30 to Day 0 pre-surgery) 
Assessment 
 
Superscripts Defined 
Informed Consent/Assent 
X 
 
1. For Screening/Randomization purposes, data from medical records 
within 30 days prior to their surgical procedure may be used. 
2. See Table 7.2: Hematology and Chemistry Testing for details on 
required labs.  
 
 
Demographics 
X 
Indication /Type of scheduled surgery 
X 
Medical, surgical, transfusion and medication history 
including radiographic contrast media within 7 days 
of surgery/ the need for irradiated RBC products 
X 
Number of prior pregnancies (females) 
X 
Physical examination including height and weight 
X 
Vital signs (HR, BP, RR) 1 
X 
Concomitant medications 
X 
EKG 1 
X 
Pregnancy test (if applicable) 1,2 
X 
Hematology panel1,2  
X 
Blood chemistry1,2  
X 
Blood type1  
X 
DAT1, IAT1 
X 
INTERCEPT RBC antibody screen (S-303-specific 
antibody screen)  
X 
Sample for HLA antibodies 
X 
TRUST score components  
X 
Randomization# 
X 
# Eligible patients will be randomized up to 7 days before or on the day 
of surgery, but prior to the start of surgery (i.e., induction of anesthesia). 
AEs/SAEs/TRs* 
X 
*The adverse event, serious adverse event and transfusion reaction 
collection period will begin at the start of surgery or the first study RBC 
transfusion, whichever is first.  Adverse events (AEs) will not be 
collected for non-transfused subjects, but vital status will be recorded at 
the time of discontinuation.  

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Table 7.1b - Baseline (Pre-Surgery) 
Study Period – Baseline (Day -1 or Day 0 Pre-Surgery) 
Assessment 
 
 
Vital signs (HR, BP, RR) 3 
X 
2 . See Table 7.2: Hematology and Chemistry Testing for details on 
required labs. 
 
3.These assessments can be combined with screening assessments if 
screening visit is also on Day -1 or Day 0 Pre-Surgery.  
 
4.Data collected on eCRFs only as available from medical records if 
performed as Standard of Care. 
 
5. Hemodynamic Parameters: Peripheral O2 Saturation, Mean Arterial 
Pressure, Central Venous Pressure. 
 
 
 
 
*The adverse event, serious adverse event and transfusion reaction 
collection period will begin at the start of surgery or the first study RBC 
transfusion, whichever is first.  Adverse events (AEs) will not be collected 
for non-transfused subjects but vital status will be recorded at the time of 
discontinuation.  
Concomitant medications3 
X 
Pregnancy test (if applicable)2,3 
X 
Hematology panel2,3  
X 
Blood chemistry2, 3  
X 
EKG3  
X4 
Hemodynamic Parameters5 
X4 
Fibrinogen Troponin 
X4 
AEs/ SAEs/TRs* 
X 
 
 

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Table 7.1c – Acute Transfusion Support Period  
Study Period - Acute Transfusion Support Period (Surgery [Day 0] to Post-operative Day 7, hospital discharge or death, whichever 
is first)  
Assessment 
Day 0 
Surgery 
Day 1 - 
7 
Superscripts Defined 
Vital signs (HR, BP, RR) 
X 
X6 
2.  See Table 7.2: Hematology and Chemistry Testing 
for details on required labs. 
4. Data collected on eCRFs only as available from 
medical records if performed as Standard of Care. 
5. Hemodynamic Parameters, if available- Peripheral 
O2 Saturation, Mean Arterial Pressure4, Central 
Venous Pressure4 
6. These assessments are required to be collected daily 
on Day 1 through Day 7 post surgery or until 
discharge.  If subject returns after discharge for a 
postoperative standard of care visit, assessments 
will be collected in eCRFs on the appropriate study 
day. 
7. Any drugs given to induce anesthesia or drugs given 
as a prophylactic in combination with anesthesia 
prior to surgery do not need to be 
recorded.  Medications given during anesthesia to 
treat an AE/SAE need to be recorded. 
8. Urine output data collected daily while a urinary 
catheter is in place. The date entered should reflect 
the start of the collection and match the visit date. 
9.  S-303 screen must be performed whenever a 
routine RBC alloantibody screen (IAT) is 
performed during the transfusion period.   
10.  For non-transfused subjects, a blood sample for 
sCr will be drawn at 48 ± 4 hours.  Daily sCr 
Concomitant medications 
 X7 
X6 
EKG 
X4 
X4 
Hematology panel2 
X 
X6 
Blood chemistry2  
X 
X6 
Serum Creatinine at 48±4 hours after end of surgery 
 
X10 
Hemodynamic Parameters3 
X5 
X6 
Fibrinogen, Troponin 
X4 
X4 
Urine output8 
X 
X6 
Procedure details 
X 
 
Study RBC crossmatch and Study RBC transfusion(s)/data 
X 
X 
DAT, IAT, INTERCEPT RBC antibody screen (S-303-specific 
antibody screen)9 
X4 
X4 
All other blood components (including non- study RBCs) 
transfused, if any 
X 
X 
Estimated blood loss from surgery 
X 
 
Estimated blood loss from other source including chest tube(s) 
  
X6 
AEs/ SAEs/TRs* 
X 
X6 

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Table 7.1c – Acute Transfusion Support Period  
Study Period - Acute Transfusion Support Period (Surgery [Day 0] to Post-operative Day 7, hospital discharge or death, whichever 
is first)  
Assessment 
Day 0 
Surgery 
Day 1 - 
7 
Superscripts Defined 
assessments will be recorded up to and including 
48 ±4 hours post surgery.  
* The adverse event, serious adverse event and 
transfusion reaction collection period will begin at 
the start of surgery or the first study RBC 
transfusion, whichever is first. AEs including 
protocol specified AEs, TRs and SAEs (see Section 
7.3) are collected through 28 days after the last 
study transfusion; also collected daily during acute 
transfusion support period.  For non-transfused 
subjects, adverse events (AEs) will not be collected 
for non-transfused subjects, but vital status will be 
recorded at the time of discontinuation.  
 
 

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Table 7.1d – Post-Operative Period  
Study Period- Post-operative Period Day 8 (or Post-discharge, if Earlier) to Day 28 after last study transfusion 
Assessment 
Day 8 
through to 
Day 28 post 
last study Tx 
Superscript Defined 
Weekly telephone calls 
X 
2.  See Table 7.2: Hematology and Chemistry Testing 
for details on required labs  
4. Data collected on eCRFs as available from medical 
records if performed as Standard of Care. 
5. Hemodynamic Parameters, if available- Peripheral 
O2 Saturation, Mean Arterial Pressure, Central 
Venous Pressure 
8. Urine output data collected daily while a urinary 
catheter is in place. The date entered should reflect 
the start of the collection and match the visit date. 
10. Laboratory results recorded in the eCRFs during this 
period will only be those assessed as clinically 
significant by the Investigator. 
*  The adverse event, serious adverse event and transfusion 
reaction collection period will begin at the start of surgery 
or the first study RBC transfusion, whichever is first. AEs 
including protocol specified AEs, TRs and SAEs (see 
Section 7.3) are collected through 28 days after the last 
study transfusion; also collected daily during acute 
transfusion support period.  Adverse events (AEs) will not 
be collected for non-transfused subjects, but vital status will 
be recorded at the time of discontinuation. 
 
Concomitant medications 
X4 
Hematology panel 2, 10   
X4 
Blood chemistry 2, 10   
X4 
Hemodynamic Parameters5 
X4 
Fibrinogen, Troponin 
X4 
Urine output8 
X4 
All other blood components (including non- study RBCs) 
transfused, if any 
X4 
AEs/ SAEs/TRs* 
X 
 

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Table 7.1e - Follow-up Visits (Day 28±3, 30, and 75±15) 
Study Period (Day 28±3, 30, and 75±15[End of Study]) 
Assessment 
28±3 days  
After last study 
transfusion 
or Early 
Termination 
30 days 
After 
Surgery 
End of Study 
(75±15 Days 
After Last 
Study 
Transfusion) 
 
Superscripts Defined 
Vital signs (HR, BP, RR) 
X 
 
 
2.  See Table 7.2: Hematology and 
Chemistry Testing for details on 
required labs  
*  The adverse event, serious adverse 
event and transfusion reaction 
collection period will begin at the start 
of surgery or the first study RBC 
transfusion, whichever is first. AEs 
including protocol specified AEs, TRs 
and SAEs (see Section 7.3) are 
collected through 28 days after the last 
study transfusion; also collected daily 
during acute transfusion support period. 
Adverse events (AEs) will not be 
collected for non-transfused subjects, 
but vital status will be recorded at the 
time of discontinuation.  
11. Assess at Day 30 post surgery via clinic 
visit, medical record or phone call. Any 
RRT that is provided prophylactically 
during surgery while the subject is on a 
bypass machine does not meet this 
endpoint. 
Concomitant medications 
X  
Hematology panel2  
X 
Blood chemistry 2  
X 
DAT, IAT 
X 
INTERCEPT RBC antibody screen (S-303-specific 
antibody screen)  
X 
X 
Sample for HLA antibodies 
X 
 
All other blood components (including non- study 
RBCs) transfused, if any 
X 
AEs/ SAEs/TRs * 
X 
Documentation of vital status and need for RRT 
X 
X11 
X 
 
 
 

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Table 7.2: Hematology and Chemistry Testing- Required (R) results and Where Available (WA)a results  
Study Period 
Screening / Randomization 
Acute Transfusion Support Period 
(Surgery [Day 0] to Post-operative 
Day 7, hospital discharge or death, 
whichever is first) 
Post-operative Period 
Follow-up Visit 
 
Baseline 
(Pre-surgery) 
 
 
Window 
Day -30 to  
Day -1 
Day -1 or  
Day 0 
pre- surgeryg 
Day 0 
Surgery 
Days 1 – 7, hospital 
discharge or death 
Days 8 to 28 after last 
study transfusion / death 
Laboratory results recorded in the 
eCRFs during this period will only 
be those assessed as clinically 
significant per the investigator.  
28±3 days after last 
study transfusion or 
Premature 
Discontinuation 
Visit 
Pregnancy test (if applicable) 
Rj 
Rj 
 
 
 
 
Hematology (CBC):  
 
 
 
 
 
 
Hematocrit (Hct) 
Rb 
WA 
R 
Rd,e,i 
WA 
R 
Hemoglobin (Hb) 
Rb 
WA 
R 
Rd,e,i 
WA 
R 
Platelets (PLT) 
Rb 
WA 
R 
Rd,e,i 
WA 
R 
RBC Count 
Rb 
WA 
R 
Rd,e,i 
WA 
R 
WBC Count 
Rb 
WA 
R 
Rd,e,i 
WA 
R 
Fibrinogen  
 
WA 
WA 
WAd 
WA 
 
Troponin 
 
WA 
WA 
WAd 
WA 
 
Blood chemistry: 
 
 
 
 
 
 
Alkaline Phosphatase (ALP) 
WA 
WA 
WA 
WAd 
WA 
WA 
Alanine Transaminase (ALT) 
WA 
WA 
WA 
WAd 
WA 
WA 
Aspartate Aminotransferase (AST) 
WA 
WA 
WA 
WAd 
WA 
WA 
Bicarbonate (CO2) 
WA 
WA 
WA 
WAd 
WA 
WA 
Blood Urea Nitrogen (BUN) 
Rb 
R  
Rh 
Rd,h,i 
WA 
R 
Calcium (Ca) 
Rb 
WA 
R 
WAd 
WA 
R 
Chloride (Cl) 
Rb 
WA 
R 
WAd 
WA 
R 
Creatinine (sCr) 
Rb 
R 
Rh 
Rc,e,f,h,i 
WA 
R 
Glucose 
Rb 
WA 
R 
Rd,i 
WA 
R 
Lactate Dehydrogenase (LDH) 
WA 
WA 
WA 
WAd 
WA 
WA 
Potassium (K) 
Rb  
WA 
R 
Rd,i 
WA 
R 
Sodium (Na) 
Rb  
WA 
R 
Rd,i 
WA 
R 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
 
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Study Period 
Screening / Randomization 
Acute Transfusion Support Period 
(Surgery [Day 0] to Post-operative 
Day 7, hospital discharge or death, 
whichever is first) 
Post-operative Period 
Follow-up Visit 
 
Baseline 
(Pre-surgery) 
 
 
Window 
Day -30 to  
Day -1 
Day -1 or  
Day 0 
pre- surgeryg 
Day 0 
Surgery 
Days 1 – 7, hospital 
discharge or death 
Days 8 to 28 after last 
study transfusion / death 
Laboratory results recorded in the 
eCRFs during this period will only 
be those assessed as clinically 
significant per the investigator.  
28±3 days after last 
study transfusion or 
Premature 
Discontinuation 
Visit 
Total Bilirubin 
Rb 
R  
R 
Rd,i 
WA 
R 
Footnotes: 
a R= required testing and reporting.  
 WA=where available. Data collected on eCRFs as available from medical records if performed as Standard of Care. 
b For Screening/Randomization purposes, data from medical records within 30 days of surgery may be used as long as laboratory tests are 
performed again prior to surgery in order to establish baseline values and confirm the subject’s continued trial eligibility.  
c A sample to measure sCr will be taken at 48±4 hours after the end of surgery and captured on a specific CRF page for that time-point. For non-
transfused subjects, a blood sample for sCr will be drawn at 48 ± 4 hours.   
d If an assessment is performed more than once in a day, the first set of results should be entered into the eCRF. 
e If a subject is discharged prior to the end of the acute transfusion support period (Day 7) but for any reason returns to the study site (e.g., re-
hospitalization or standard care) within this acute transfusion support period, lab values routinely collected as standard of care should be recorded 
in the eCRF.  
f If serum creatinine is measured multiple times in a day, the worst daily value should be recorded in the eCRF. 
g  These assessments can be combined with screening assessments if screening visit is also on Day -1 or Day 0 Pre-Surgery. 
h  Assessments that contribute to the AKI should be measured at approximately the same time every day during the treatment period. 
i  These assessments are required to be collected daily on Day 1 through Day 7 post surgery or until discharge.  If subject returns after discharge for 
a postoperative standard of care visit, assessments will be collected in eCRFs on the appropriate study day. 
j Negative urine or serum pregnancy test. 
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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ASSESSMENT OF EFFICACY 
7.2.1 
Efficacy Parameters 
The primary efficacy endpoint is the proportion of patients with a diagnosis of renal 
impairment defined as any increase in sCr ≥0.3 mg/dL (or 26.5 µmol/L) from the pre-
surgery baseline within 48±4 hours after the completion of surgery.  If any subject 
meets this criterion before receiving a study transfusion, that particular event will not be 
included in this analysis. 
Treatment difference (Test−Control) will be compared between the subjects who were 
randomized to receive INTERCEPT RBCs vs. those randomized to receive 
conventional RBCs with a non-inferiority margin of 50% increase from the Control rate 
and two-sided 0.05 alpha level.    
Secondary efficacy parameters that will be assessed include: 
• 
The proportion of patients with a diagnosis of stage I, II or III Acute Kidney Injury 
(KDIGO 2012) based on changes in sCr levels from baseline and the need for 
renal replacement therapy (RRT) post-surgery.  
• 
Mortality or the need for RRT by Day 30 post-surgery. 
7.2.2 
Methods and Timing of Efficacy Parameters  
Hemodynamic and laboratory measures will be assessed pre-operatively (Day -1 or pre-
operatively on the day of surgery) and daily from post-operative Day 1 through post-
operative Day 7, hospital discharge or death, whichever occurs first. Serum creatinine 
will be determined on a daily basis during the acute transfusion support period and, in 
order to capture the primary efficacy endpoint, a sample for sCr will be taken also at 
48±4 hours after the end of surgery.  
The rest of the efficacy parameters will be collected only as available in the medical 
record (refer to Study Schedule of Assessments; Section 7.1).  
An end of acute transfusion period a blood sample will be collected at Day 7, hospital 
discharge, or death, whichever occurs first. If a subject is discharged prior to Day 7 but 
returns to the study site for a standard of care visit on Day 7, blood samples should be 
obtained on that day for a complete blood count and sCr determination.  

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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ASSESSMENT OF SAFETY 
7.3.1 
Safety Parameters  
The primary safety outcome measures are the: 
• 
Proportion of patients with any treatment-emergent adverse events (TEAEs) 
possibly, probably or definitely related to study RBC transfusion through 28 days 
after the last study transfusion.  
• 
Proportion of patients with treatment emergent antibodies with confirmed 
specificity to INTERCEPT RBCs).  
Additional safety assessments will include, but are not limited to: 
• 
Treatment-emergent AEs through 28 days after the last study transfusion. 
• 
Treatment-emergent SAEs through 28 days after the last study transfusion. 
• 
Transfusion reactions (as defined by the CDC National Healthcare Safety Network 
[NHSN] Hemovigilance Module protocol) through 28 days after last study 
transfusion. 
• 
Treatment-emergent immunization to RBC allo-antigens through 28±3 days after 
the last study transfusion.  
• 
Treatment-emergent immunization to HLA allo-antigens through 28±3 days after 
the last study transfusion. 
7.3.1.1 Definition of Adverse Event 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a pharmaceutical (investigational) product and which does not necessarily 
have a causal relationship with this treatment. An AE can therefore be any unfavorable 
and unintended sign (including an abnormal laboratory finding), symptom, or disease 
temporally associated with the use of a medicinal (investigational) product whether or 
not related to the medicinal (investigational) product (ICH E2A II/A/1, 21 CFR 312.32).  
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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7.3.1.2 Definition of Serious Adverse Event 
A Serious AE (SAE) is any untoward medical occurrence that at any dose results in any 
of the following outcomes: 
• 
Death 
• 
Life-threatening event (results in an immediate risk of death from the reaction as it 
occurred) 
• 
Inpatient hospitalization or prolongation of existing hospitalization  
• 
A persistent or significant disability/incapacity 
• 
A congenital anomaly/birth defect 
• 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the patient or subject and/or may require 
intervention to prevent one of the outcomes listed in this definition.  
The terms "severe" and "serious" are not synonymous. Severity refers to the intensity of 
an adverse event (e.g., rated as mild, moderate, or severe, life-threatening or death 
according to National Cancer Institute Common Terminology Criteria for Adverse 
Events (NCI CTCAE) criteria). Severity and seriousness need to be assessed for each 
adverse event recorded on the eCRF. 
SAE must be reported by the Investigator to the Sponsor immediately (i.e., no more 
than 24 hours) after learning of the event. 
7.3.1.3 Unexpected Adverse Event 
Any adverse event occurring in one or more subjects in a research protocol, the nature, 
severity, or frequency of which is not consistent with (a) the applicable product 
information (protocol, informed consent/assent, Investigator’s Brochure or other 
product labeling), or (b) the expected natural progression of any underlying disease, 
disorder or condition of the subject experiencing the adverse event and the subject’s 
predisposing risk factor profile for the adverse event.  
7.3.1.4 Definition of Unanticipated Adverse Device Effects 
Any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or possibly, probably or definitely related to  a device, if that effect, problem, 
or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects (21 CFR 812.3(s)). 
7.3.1.5 Definition of Renal Impairment 
For the purposes of this study, renal impairment is defined as an increase in sCr ≥ 0.3 
mg/dL from the pre-surgical baseline concentration. 
7.3.1.6 Definition of Acute Kidney Injury (AKI) 
For the purposes of this study, a definition of an acute kidney injury during the study is 
based on the Kidney Disease: Improving Global Outcomes (KDIGO) AKI workgroup 
definition (KDIGO 2012) criteria as: 
• 
An increase  sCr ≥50% of the pre-surgery baseline level within 7 days post-
surgery, OR 
• 
An increase in sCr ≥0.3 mg/dL (26.5 µmol/L) from pre-surgery baseline within 48 
hours of surgery. 
For the purposes of this study, acute kidney injury stages are defined as follows 
(KDIGO AKI workgroup):  
Stage 1   
Serum creatinine:  1.5–1.9 times baseline within 7 days after surgery  
OR 
≥0.3 mg/dl (≥26.5 µmol/L) increase within 48 hours of surgery 
 
Stage 2 
Serum creatinine:  2.0–2.9 times baseline within 7 days after surgery 
 
Stage 3 
Serum creatinine:  3.0 times baseline within 7 days after surgery 
OR 
Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 µmol/L) 
OR 
Initiation of renal replacement therapy 
 
If a renal event during the study fulfills KDIGO laboratory criteria as specified above, 
this may constitute an AE/SAE of AKI as per Investigator’s clinical judgement. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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7.3.1.7 Renal Replacement Therapy 
For the purposes of this study RRT is defined as the institution of hemodialysis or 
peritoneal dialysis to treat acute or chronic renal failure associated with a decrease in 
glomerular filtration rate with or without fluid overload, severe acidosis, hyperkalemia 
or other electrolyte abnormalities. Dialysis performed solely to treat toxin/poisonings or 
performed preventatively during surgery while on a bypass machine, will not be 
considered RRT in the terms of meeting a secondary endpoint. 
7.3.1.8 Treatment-emergent HLA antibodies 
For the purposes of this study, HLA Class I and II antibody testing will be performed in 
a central laboratory according to the method described by Triulzi et al. (Triulzi 2009). 
Screening tests for anti-HLA Class I and II will be performed with multi-antigen bead 
kits (LabScreen LSM12, LabScreen Mixed, One Lambda, Canoga Park, CA) according 
to the manufacturer’s instructions. Data will be using two different normalized 
background (NBG) ratio cut-offs.  The data will be analyzed using the manufacturer’s 
recommended cutoff of a NBG ratio of 2.2.  The data will also be analyzed using NBG 
ratios of the mean plus three or five standard deviations of a log transformed 
distribution of values for plasma samples for non-transfused males, as described (Triulzi 
2009).  
7.3.1.9 Definition of Culture Proven Sepsis/Septic Shock 
For the purposes of this study, transfusion related sepsis/septic shock is defined as a 
positive culture from blood and/or CSF and a study RBC product with matching 
bacterial strains, with at least 3 of the following signs of septic inflammatory response 
syndrome (SIRS) (Levy 2003): 
• 
Temperature < 36°C or > 38°C 
• 
Heart rate > 90 bpm 
• 
Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg 
• 
White blood cell count > 12,000 or < 4,000 cells/mm3 or > 10% bands 
7.3.1.10 Definition of Transfusion Reaction 
A transfusion reaction is defined as an undesirable response or effect in a patient 
temporally associated with and possibly, probably or definitely related to the 
administration of blood or blood components. The current version of the CDC NHSN 
Hemovigilance Protocol definitions must be used when recording transfusion reaction 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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terms in this study (APPENDIX  3). 
 Clinically Significant Antibodies (Chapman et al. 2004) 
Clinically significant antibodies are those that are capable of causing patient morbidity 
due to accelerated destruction of a significant proportion of transfused red cells. 
  Delayed Serological Transfusion Reaction (DSTR) (Ness et al. 1990; 
Garratty 2012)  
The DSTRs are where a particular alloantibody can be shown to be present in the 
patient’s plasma, on the transfused donor RBCs and/or in an eluate from these RBCs, 
but no clinical or laboratory signs of hemolytic anemia (HA) are present. Regardless of 
the mechanism, the persistence of a positive DAT does not correlate with the presence 
or absence of clinical hemolysis (Ness 1990). 
The DSTR may be in the form of new antibodies or a rising titer of antibodies in 
patients with pre-existing antibodies (patients with pre-existing antibodies specific to 
INTERCEPT RBCs at baseline evaluation will be excluded in ReCePI). DSTR will be 
categorized as described in the NHSN Hemovigilance Protocol v 2.5.2 (APPENDIX  3). 
  Delayed Hemolytic Transfusion Reaction (DHTR) (Ness et al. 1990)  
A DHTR is defined as a DSTR that showed clinical and/or laboratory evidence of 
hemolysis. Table 7.3 shows some differential diagnoses of hemolytic transfusion 
reactions. DHTR will be categorized as described in the CDC NHSN Hemovigilance 
Protocol v 2.5.2 (APPENDIX  3). 
  Acute Hemolytic Transfusion Reaction (AHTR) (Ness 1990)  
An AHTR is defined as the rapid destruction of RBCs during, immediately after, or 
within 24 hours of cessation of transfusion. Clinical and laboratory signs of hemolysis 
are present AHTR will be categorized as described in the CDC NHSN Hemovigilance 
Protocol v 2.5.2 (APPENDIX  3).  
 Hyper-hemolysis Syndrome  
Hyperhemolysis is characterized by a hemolytic transfusion reaction that leads to a life-
threatening anemia, with drops in Hb and Hct to levels markedly lower than those 
present before transfusion. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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Table 7.3 Some Differential Diagnoses of Hemolytic Transfusion Reactions 
Immunologically caused hemolysis 
Autoimmune hemolytic anemia 
  ‘Warm’ antibody induced hemolytic anemia 
   Cold hemagglutinin disease 
   Paroxysmal cold hemoglobinuria 
Drug induced immune hemolytic anemia 
Passenger lymphocyte syndrome after stem cell or solid organ transplantation 
Hemolytic disease of a newborn 
Acute episodes of non-immunologically caused hemolysis 
Hereditary erythrocyte defects 
   Defects of red blood cell (RBC) enzymes (e.g., glucose-6-phosphate 
   dehydrogenase deficiency) 
   Hemoglobinopathies (e.g., sickle cell disease) 
   Thalassemia 
   Defects of RBC membrane 
   Congenital erythropoietic porphyria 
Paroxysmal nocturnal hemoglobinuria 
Infections 
   Bacterial (bartonellosis; hemolytic-uremic syndrome caused by 
   enterohemorrhagic Escherichia coli; severe infections by bacteria 
   producing hemolyzing toxins (e.g., Clostridium perfringens)) 
   Protozoal (malaria, babesiosis) 
Mechanical hemolysis by artificial heart valves or by extracorporeal 
circulation 
Thrombotic-thrombocytopenic purpura (Moschowitz disease) 
HELLP syndrome during gravidity 
Intoxications 
Near drowning 
Source: Strobel E. 2008. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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7.3.1.11 Suspected Hemolytic and Serologic Transfusion Reactions after Enrollment and 
Transfusion with Study RBC Components 
 Assessment of Immune Reactivity to INTERCEPT RBCs 
At the time of RBC crossmatch and at specified times during the study [screening 
(Table 7.1a) during the acute transfusion support period (Table 7.1c) and at Day 28 
(±3 days) and day 75 (± 15 days) (Table 7.1e) post first study transfusion;], patient 
plasma/serum samples are tested for the presence of antibody specific to INTERCEPT 
RBCs. The RBC screening panel uses a gel card agglutination format and has been 
validated at the Blood Center of Wisconsin for this purpose. The primary RBC 
screening panel is composed of reagent RBCs from 3 blood group O donors and is 
analogous to routine screening panels used in regular blood banking practice. The 
secondary RBC screening panel is composed of reagent RBCs from 6 different blood 
group O donors and is analogous to secondary panels used in routine practice to identify 
antibody specificity for a range of common RBC allo-antigens and is used if reactivity 
is detected in the primary screening assay. The panel donors were specifically antigen-
phenotyped for major blood group systems similar to the commercially available 
reagent cells panels for antibody identification and differentiation. The primary and 
secondary RBC screening panel cells have been prepared as both INTERCEPT-treated 
and untreated RBCs. Each panel has three sets of RBCs made from the identical group 
O donors: untreated RBC; treated RBCs consisting of cells carrying a “high” level of S-
303 (amustaline) adducts (comparable to the INTERCEPT RBCs prepared with the 
“Original process” and cells carrying a “low” level of S-303 (amustaline) adducts 
(representative of INTERCEPT RBCs prepared with the “Current process”. The 
primary screening panel is designed as a sensitive screening test for both common RBC 
alloantibodies and for INTERCEPT RBC-specific antibodies. The secondary panel is 
designed to determine the specificity of any antibodies detected in the primary screen 
and to distinguish common RBC alloantibodies from INTERCEPT RBC-specific 
antibodies. 
By including cells with both low and high acridine adducts there is an increased 
sensitivity for antibody against acridine adducts and, much in the same way that 
homozygous donors are used to produce commercially prepared red cells, there is a 
greater potential for detecting low affinity or low titer (weak) antibodies. Thus, the 
panels have the capability to detect an antibody specific to INTERCEPT RBCs even in 
the presence of alloreactivity from an intrinsic antigen. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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The patient samples are tested against the screening panel(s) of reagent RBCs to 
identify an antibody specific to INTERCEPT RBCs. The gel card agglutination test 
results are scored (0, weak positive, 1+, 2+, 3+, 4+) and the reactivity is classified as 
follows:  
• 
If the antibody screening score is 0 for all the untreated and INTERCEPT RBCs 
on the primary RBC screening panel, the sample is considered “non-reactive” with 
no antibodies (neither an intrinsic alloantibody or INTERCEPT RBC-specific 
antibody) present in the patient’s serum and thus no requirement for antibody 
identification with the secondary antibody identification panel. Neither the 
secondary RBC screening panel nor additional tests are required. The patient 
continues to receive study RBC components according to the protocol. In addition, 
each unit of study RBC is crossmatched to the patient’s plasma using an 
antiglobulin (AHG) gel card test, providing a further level of protection to detect 
incompatibility, including that caused by INTERCEPT RBC-specific antibodies. 
• 
If the results of the primary RBC screening panel show concordant 3/3, 2/3, or 1/3 
reactive with BOTH the INTERCEPT treated reagent RBCs and the corresponding 
Control untreated RBCs, the sample will be considered “presumed allo-reactive” 
antibody to an intrinsic red cell antigen. The sample is tested against the secondary 
RBC screening panel to identify and confirm the specificity of the allo-antibody 
producing the reaction according to standard blood banking rules (reactivity with 
three RBC cells bearing the RBC antigen, and non-reactivity with three RBC that 
lack the antigen). If the antibody that is causing the agglutination is identified and 
confirmed, then the sample is considered “allo-reactive” for that RBC alloantigen. 
In this setting, lack of reactivity with all (at least three) INTERCEPT treated RBC 
cells that lack the RBC alloantigen, will rule out INTERCEPT RBC antibody 
specificity. The patient continues on study and will receive compatible (cross 
matched) study RBC components.  
• 
If INTERCEPT RBC-specific antibodies cannot be ruled out, or agglutination is 
visible for all the untreated RBC cells in the panel, (i.e., “pan-reactive”), the 
patient will be discontinued from the study transfusions and followed up at 
planned visits for safety until study completion.  
• 
If the primary RBC screening panel score is positive with 2/3 or 3/3 of the 
INTERCEPT RBCs carrying S-303 (amustaline) adducts at either ‘high” and/or 
“low” level AND 0/3 with the corresponding Control untreated RBCs which lack 
S-303 adducts, the sample is classified as “reactive for -INTERCEPT RBC-
specific antibodies” and the sample will be sent to the central testing lab for further 
characterization of specificity. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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Weak false positive reactions occur with serological tests due to variation in 
performance of the test and manual interpretation of the results (Aubuchon 2008). The 
provisos below are put in place to ensure that patients are not inappropriately withdrawn 
from the study and are in keeping with the current blood bank policies that repeat 
reactive results with a minimum of two tests are required for a positive test in 
serological viral marker assays.  
• 
Should only 1/3 INTERCEPT RBC cells in the primary panel test reactive for the 
S-303 labeled cells without reactivity for the untreated RBCs, that INTERCEPT 
RBC cell (at both high and low levels of surface bound acridine) and its untreated 
control will be considered “initially reactive” and the test will be repeated in 
duplicate on that cell only (of the three cells in the primary panel), and the 
secondary panel will also be tested. In this setting the secondary panel serves to 
increase the sensitivity for INTERCEPT RBC- specific antibodies by testing a 
larger number of INTERCEPT RBC cells. Negative reactivity to both repeat tests 
of the primary panel cell and negativity with the secondary panel will be 
considered a negative test. Reactivity in at least one of two repeat primary panel 
cells INTERCEPT RBC cells or any INTERCEPT RBC cell in the secondary 
panel without reactivity with the corresponding untreated RBC will be a 
considered positive test for INTERCEPT RBC reactivity. The sample will be sent 
for additional characterization at the Central immunohematology reference 
laboratory to include inhibition studies to determine specificity of observed 
reactivity. (see APPENDIX 2 for a Characterization plan for potential antibody to 
INTERCEPT RBCs- Addendum to the CLI 00125 Protocol).  
The above-mentioned Central Laboratory protocol will ensure that the minimum criteria 
for discontinuation of a patient from study transfusions requires reactivity with at least 
two INTERCEPT RBC cells in the panel with no reactivity with the corresponding 
untreated control, or repeat reactivity with a single INTERCEPT RBC cell with an 
unreactive determination with its untreated control. 
The patient will be followed up until completion of all study visits, and, if transfused 
with study RBCs, and evidence for clinical hemolysis will be investigated. A procedure, 
for patient and laboratory sample management for studies involving INTERCEPT 
Blood System for RBCs when a reactive S-303 result is obtained (S-303 Reactive 
Samples: Management of Patients and Samples; REF 01606), will be followed. 
To discriminate whether an antibody with specificity for INTERCEPT RBCs is 
physiologically active or clinically significant, any one of the following criteria 
indicative of accelerated RBC clearance in the absence of active bleeding, organ-
mediated RBC sequestration, severe erythroid hypoplasia or other concurrent medical 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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cause for acute anemia not associated with transfusion, should be present: 
a. During the first 7 days following transfusion, the patient’s hemoglobin level has 
returned to the pre-transfusion level. 
b. During Days 8-14 following transfusion, patient’s hemoglobin level has 
declined below the pre-transfusion hemoglobin level for this transfusion. 
Beyond Day 14 post-transfusion, the assessment of a clinically significant change in the 
patient’s post-transfusion hemoglobin level compared with prior responses for 
comparable hemoglobin doses transfused as judged by the Investigator. 
Other clinical signs and symptoms that may be considered by the Investigator to judge 
whether accelerated RBC clearance is occurring, include: 
Extravascular hemolysis 
• 
falling hematocrit 
• 
increased unconjugated bilirubin (≥1.5-fold higher than the upper limit of normal) 
• 
fever 
• 
positive DAT  
• 
micro-spherocytes on peripheral smear 
• 
decreased or absent haptoglobin levels 
• 
elevated reticulocyte count 
Intravascular hemolysis 
• 
shock syndrome 
• 
hypotension (BP lower than 90/60 mmHg) 
• 
back pain  
• 
plasma free hemoglobin increased 
• 
increase in lactate dehydrogenase (LDH) ≥1.5-fold higher than the upper limit of 
normal (LDH ≥1.5×ULN) 
• 
urine hemoglobin (hemoglobinuria) 
• 
urine hemosiderin (hemosiderinuria) 
• 
decreased or absent haptoglobin levels 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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• 
elevated reticulocyte count 
• 
fragmented RBC on peripheral smear 
• 
DAT may be positive 
Plasma/serum samples for patients with confirmed antibodies specific to INTERCEPT 
RBCs (i.e., a DSTR, DHTR or any ATR) will be assessed for hemolytic potential 
according to a defined Central Laboratory protocol, provided to the sites and filed in the 
Investigator Site File (see APPENDIX  2) to define physiologic significance. For the 
purposes of this protocol, the development of a new antibody specific to INTERCEPT 
RBCs in the patient and with evidence of accelerated RBC clearance, in the absence of 
clinical alternative explanations (e.g., concomitant RBC alloantibodies, sickle cell 
disease, etc.) will be classified as a hemolytic transfusion reaction. All INTERCEPT 
RBC-specific antibodies and all hemolytic TRs will be reported to the FDA and DSMB. 
  Investigation of Hemolytic Potential 
Investigation of the hemolytic potential of any INTERCEPT RBC-specific antibodies 
found in the ReCePI study will be conducted by a Central Laboratory according to the 
document titled “Evaluation of Reactivity with INTERCEPT RBC” provided to the 
sites and filed in the Investigator Site File and the protocol in APPENDIX  2. Patient 
samples will be managed using the supplemental instructions for patient and laboratory 
sample management for studies involving INTERCEPT Blood System for RBCs when 
a reactive S-303 result is obtained (S-303 Reactive Samples: Management of Patients 
and Samples; REF 01606) Possible studies may include: 
• 
Antibody specificity via inhibition studies (inhibited by soluble acridine or not) 
• 
Antibody characterization: 
• 
Immunoglobulin isotype and IgG subclass (IgM, IgG1, 2, 3 or 4) 
• 
Antibody titer 
• 
Persistence and titer over time 
• 
Thermal spectrum and phase of reaction 
• 
Complement-mediated in vitro hemolysis 
• 
Investigation of concurrent antibodies to intrinsic RBC allo-antigens 
• 
Monocyte Monolayer Assay for clinical significance (Arndt and Garratty 2004) 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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7.3.1.12 
Abnormal Test Findings 
The criteria for determining whether an abnormal objective test finding should be 
reported as an adverse event are as follows: 
• 
Test result is associated with accompanying symptoms, and/or 
• 
Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or 
• 
Test result leads to a change in trial dosing or discontinuation from the study 
participation, significant additional concomitant drug treatment, or other therapy, 
and/or 
• 
Test result is considered to be an adverse event by the Investigator or Sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does 
not constitute an adverse event. Any abnormal test result that is determined to be an 
error does not require reporting as an adverse event. 
7.3.2 
Methods and Timing of Safety Parameters 
The use of intravenous radiographic contrast media will be documented starting 7 days 
prior to surgery, as will details related to the specific surgical procedure (type of 
procedure, start and end times), RBC components transfused, all other blood 
components transfused, estimated blood loss from the surgical procedure, concomitant 
medications, intraoperative cell recovery and reinfusion, hemodilution, and nadir 
temperature. Additionally, daily estimated blood loss from chest tube(s) and from other 
sources, and day of chest tube removal will be recorded.  Safety events (TRs, AEs and 
SAEs) will be documented on a daily basis during the acute transfusion support period 
(through Day 7).  
Subjects will continue to be monitored through a post-surgical follow-up period for up 
to 28 days after the last study transfusion, or death, whichever occurs first.  During this 
period, subjects will be monitored for safety events.  Blood samples for laboratory 
studies, DAT/IAT and for antibodies specific to INTERCEPT RBC- associated antigens 
will be obtained at 28±3 days after the last study transfusion and at end of study. 
All samples obtained for determination of human leukocyte antigen (HLA) will be 
stored for up to 1 year after the study has completed. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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REPORTING PERIOD 
All safety events will be collected from the start of surgery or the start of the first study 
transfusion (whichever is first) through 28 days after the last study transfusion or death, 
whichever is first.   
Vital status and need for RRT of all subjects will be collected at 30 days after the end of 
surgery and at the end of study visit (Day 75 ±15 days).   
Blood sample for assessment of sCr will be collected on post-operative day 2 (at 48 ± 
4 hours post end of surgery) for the primary endpoint.  For non-transfused subjects, a 
blood sample for sCr will be drawn at 48 ± 4 hours post-surgery. 
Blood samples for assessment of INTERCEPT RBC-specific antibody, HLA antibodies 
and chemistry and hematology laboratory studies at 28+3 days after the last study 
transfusion.  
Blood samples for assessment of INTERCEPT RBC-specific antibody will also be 
obtained 75 ±15 days after the last study transfusion.  
 
RECORDING AND REPORTING ADVERSE EVENTS 
7.5.1 
Assessing Severity of an Adverse Event 
The Investigator will assess the severity of each adverse event based on the NCI 
Common Terminology Criteria for Adverse Events (CTCAE) (APPENDIX  4) and 
summarized in Table 7.4.  
 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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Table 7.4 Severity Assessment of Adverse Events 
Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated. 
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL  
Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL  
Grade 4: Life-threatening consequences; urgent intervention indicated. 
Grade 5: Death related to AE. 
Link to NCI CTCAE 5.0:  
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x
11.pdf (APPENDIX  4) 
 
Note the distinction between the severity and the seriousness of an adverse event. A 
severe event is not necessarily a serious event. For example, a headache may be severe 
(interferes significantly with patient's usual function) but would not be classified as 
serious unless it met one of the criteria for serious adverse events.  Consistency between 
severity and seriousness assessments should be ensured by the Investigator.   
7.5.2 
Assessing Seriousness of an Adverse Event 
The Investigator will assess if an AE resulted in any one or more of the following 
outcomes that result in classification of the event as an SAE: death, a life-threatening 
event (results in an immediate risk of death from the reaction as it occurred), inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, a congenital anomaly/birth defect, or another important medical 
event (Section 7.3.1.2).  
7.5.3 
Assessing Causality of an Adverse Event 
The Investigator’s assessment of causality must be provided for all adverse events 
(serious and non-serious). An Investigator’s causality assessment is the determination of 
whether there exists a reasonable possibility that the investigational product caused or 
contributed to an adverse event. If the Investigator does not know whether or not 
investigational product caused the event, then the event will be handled as “possibly 
related to investigational product” for reporting purposes.  
Adverse events assessed by the Investigator to be related (possible, likely/probable) to 
the investigational product also must be evaluated as a Transfusion Reaction and 
classified per the CDC NHSN Hemovigilance Protocol (APPENDIX  3). 
The standard nomenclature for defining the causal relationship between an AE and the 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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blinded study product transfused is listed in Table 7.5. 
Table 7.5 Relationship between Investigational Product and Adverse Events 
Imputability Level 
Explanation 
Excluded 
When there is conclusive evidence beyond reasonable doubt that the 
adverse event can be attributed to alternative causes 
Unlikely  
When the evidence is clearly in favor of attributing the adverse event to 
causes other than the study transfusion 
Possible 
When the evidence is indeterminate for attributing the adverse event to 
the study transfusion or an alternate cause 
Likely/Probable  
When the evidence is clearly in favor of attributing the adverse event to 
the study transfusion 
Certain/Definite 
When there is conclusive evidence beyond reasonable doubt that the 
adverse event can be attributed to the study transfusion 
7.5.4 
Assessing Relationship to the INTERCEPT Blood System Device 
The Clinical Investigator in collaboration with the blood transfusion service staff will 
assess whether there is a reasonable possibility that the INTERCEPT Blood System for 
Red Blood Cells medical device used for preparation and or processing of the blood 
component caused or contributed to an AE. Determination of whether there is a 
reasonable possibility that an INTERCEPT component caused or contributed to an AE 
includes assessing whether a device malfunction occurred during the preparation of the 
blinded study RBC component. 
7.5.5 
Reporting Requirements   
The AE, SAE, and TR collection period will begin at the start of surgery or the first 
study RBC transfusion, whichever is first. AEs including protocol specified AEs, TRs, 
and SAEs (see Section 7.3) are collected daily during the acute transfusion support 
period and as reported through 28 days after the last study transfusion.  Each AE is to be 
assessed to determine if it meets the criteria for an SAE. If an SAE occurs, expedited 
reporting will follow regional and international regulations, as appropriate.  Adverse 
events (AEs) will not be collected for non-transfused subjects. Vital status will be 
reported for randomized and non-transfused subjects at the time of discontinuation. 
If an SAE occurs, the Investigator must notify Cerus or its designated safety representative 
within 24 hours after becoming aware of the event by entering in the eCRF.  When reporting 
SAEs to Cerus, the Investigator will ensure the report includes the severity, seriousness criteria 
or criterion, and causality assessments as detailed in section 7.5. 
Recording the data directly into the eCRF is the preferred method to send this information to the 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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project contact for SAE receipt.  In circumstances where the Investigator is unable to record the 
data on the eCRF, the Investigator must notify Cerus Product Safety via e-mail or the PPD 
Hotline within 24 hours of the site's awareness.  Sponsor and Contract Research Organization 
(CRO) contact information is provided in Table 7.6. 
Table 7.6 Cerus Product Safety Contact Information   
Name, Title (Study Role) 
Phone 
Address 
 ePIP (protocol inquiries) 
 N/A 
No longer used 
PPD Safety Hotline  
(SAE reporting if Medidata Rave is unavailable) 
800-201-8725 
N/A 
Cerus Product Safety Team 
N/A 
ReCePISafety@cerus.com 
Christine Ernst, MD, PhD  
Sr. Director, Clinical Research & Medical Affairs 
(Medical Monitor) 
925-288-6259 
cernst@cerus.com 
Richard Benjamin, MD, PhD 
Chief Medical Officer 
(Back-up Medical Monitor) 
925 288-6020 
rbenjamin@cerus.com 
 
Investigators must also comply with local requirements for reporting SAEs to the 
Institutional Review Board/Ethics Committee (IRB/EC). 
For all SAEs, the Investigator is obligated to pursue and provide information to Cerus 
or its representative in accordance with the timeframes for reporting specified above.  In 
addition, an Investigator may be requested by Cerus or its designee to obtain specific 
additional follow-up information in an expedited fashion. This information may be 
more detailed than that captured on the adverse event case report form. In general, this 
will include a description of the adverse event in sufficient detail to allow for a 
complete medical assessment of the case and independent determination of possible 
causality. Information on other possible causes of the event, such as concomitant 
medications and illnesses must be provided. In the case of a patient death, a summary of 
available autopsy findings must be sent as soon as possible to Cerus or its designated 
representative.  
7.5.6 
Reporting Device Malfunctions 
Blood centers are required to report any malfunctions of the INTERCEPT Blood 
System for RBCs medical device on the eCRFs. If a device malfunction impacts the 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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health of a person (patient, user or other) during the study, it may also be considered an 
AE/SAE. The Investigator must notify Cerus Product Safety. Sponsor contact 
information is provided in Table 7.6. If a device malfunction occurs at the participating 
hospitals sites, the site will complete a Device Malfunction Form. 
 
DATA AND SAFETY MONITORING BOARD (DSMB) AND INTERIM 
ANALYSIS 
The study data and safety will be monitored on a regular basis by an independent Data 
and Safety Monitoring Board (DSMB). The primary responsibility of the DSMB is to 
ensure patient safety and review protocol compliance for data collection. The DSMB 
will be assembled by the Sponsor and composed of transfusion medicine experts, 
surgeon(s) and a statistician. DSMB members will be independent of the Sponsor.  The 
DSMB will review safety data and make recommendations according to the current 
DSMB charter. 
Aside from the blinded interim analysis for sample size re-estimation performed in 
October 2021 that resulted in the reduction in study size from 600 to ≥292 patients, no 
other interim analysis is planned for this study to compare treatment differences with 
respect to efficacy or safety at any time prior to the completion of the study.  Specific 
stopping rules, developed for safety considerations, are defined in Section 4.6. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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8 
STATISTICS 
 
STATISTICAL METHODS  
8.1.1 
Efficacy Analysis 
For the primary efficacy endpoint, the treatment difference (Test – Control) and its two-
sided 95% confidence interval (CI) will be estimated from Cochran-Mantel-Haenszel 
(CMH) test stratified by baseline sCr (sCr ≥1.2 mg/dL vs. < 1.2 mg/dL) and cardiac 
surgery group (more at risk for renal complications vs. less at risk) performed. The 
upper bound of the two-sided 95% CI will be compared with the 50% of the observed 
Control rate. Non-inferiority will be achieved if the upper bound is less than the 50% of 
the observed Control rate.  For the non-inferiority test, the null and alternative 
hypotheses (H0 and H1, respectively) will be formulated as follows: 
𝐻𝐻0: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇−𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶≥50% × 𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶     𝑣𝑣𝑣𝑣.    𝐻𝐻1: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇−𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶< 50% × 𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶,    
 
where 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 and 𝑃𝑃𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 are the event rates for Test (INTERCEPT) and Control groups, 
respectively, and 𝑃𝑃෠𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶 is the observed Control rate. 
Same CMH test will be used for assessment of treatment differences for the secondary 
efficacy endpoints.  As a sensitivity analysis, logistic regression will be utilized to 
estimate the treatment differences after controlling for baseline sCr, cardiac surgery 
group performed and other covariates to be detailed in the statistical analysis plan 
(SAP). 
8.1.2 
Safety Analyses 
Treatment- emergent AEs (defined as AEs with an onset date/time that is on or after the 
start date/time of the first study transfusion) will be summarized by treatment group, 
system organ class (SOC), and preferred term. Descriptive summaries of safety 
measures will be based on observed data. No imputation of missing scores will be 
implemented. 
8.1.3 
Subgroup Analyses 
Subgroup analysis by the randomization stratification variables (clinical site, pre-
surgery renal impairment, and cardiac surgery group) and by demographic variables 
such as age group (≤18, 19 to 65, and >65 years old), sex, and race will be presented for 
primary and secondary efficacy endpoints. 
Additional subgroup analysis may also be presented as suggested by the data. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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DETERMINATION OF SAMPLE SIZE 
A total of at least 292 transfused subjects, approximately 146 per arm, are planned to 
generate sufficient efficacy and safety data for the Test and Control components in 
patients undergoing cardiac surgery procedures. 
For the primary efficacy endpoint, a non-inferiority test will be conducted to assess for 
treatment difference (Test − Control).  By assuming the proportion of patients with 
∆sCr ≥0.3mg/dL to be 30% in the Control arm and no more than 50% increase from the 
Control rate as the non-inferiority margin, a sample size of 292 patients (146 per arm) 
will provide approximately 80% power to declare non-inferiority at the two-sided 0.05 
alpha level, assuming the true treatment difference is zero.  
 
CRITERIA FOR TERMINATION OF THE STUDY 
No statistical stopping rules for efficacy will be carried out for this trial. However, 
specific stopping rules for safety considerations based on development of specific 
immune reactivity to INTERCEPT RBCs and life-threatening or fatal adverse events 
will be implemented as described in Section 4.6.  
The Sponsor may stop the trial for any reason; the reason for trial cessation will be 
documented. 
 
HANDLING OF DROPOUTS OR MISSING DATA 
For the primary analysis of the primary efficacy endpoint, missing data will be noted as 
such without imputation. Multiple imputation may be explored as an additional 
analysis.  
 
DEVIATIONS FROM THE STATISTICAL PLAN 
Any changes in the planned analyses specified in this protocol will be documented. The 
reasons for the modifications and when the changes were made will also be 
documented.  
 
SELECTION OF SUBJECTS TO BE ANALYZED 
The primary efficacy analysis group will be based on the modified intent-to-treat 
(mITT) population, including all randomized subjects who undergo cardiac surgery and 
receive one or more study RBC transfusions from randomization to within the first 48 
hours post-surgery, hospital discharge, or death, whichever occurs first, and 
summarized under their assigned treatment group, regardless of the type of RBC 
components transfused.   

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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The safety analysis group will be based on the safety population and include all 
randomized subjects who have received any study transfusions during the study. Safety 
analyses will be performed using the Safety Population and summarizing by actual 
treatment group received. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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9 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS   
Prior to participating in the study, the Investigator agrees to provide Cerus 
representatives or their designees direct access to source documents for trial-related 
monitoring and auditing. The quality representative(s) of the Sponsor may visit a 
clinical facility or blood center to ensure proper conduct of the protocol, recording of 
data, and maintenance of records. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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10 
QUALITY CONTROL AND QUALITY ASSURANCE 
 
MONITORING 
During trial conduct, Cerus or its agent will conduct periodic monitoring visits to ensure 
that the protocol and Good Clinical Practices (GCPs) are being followed. The monitors 
may review source documents to confirm that the data recorded on eCRFs are accurate. 
The Investigator and institution will allow Cerus monitors or its agents and appropriate 
regulatory authorities direct access to source documents to perform this verification. 
The trial site may be subject to review by the institutional review board 
(IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed 
by Cerus and/or to inspection by appropriate regulatory authorities. 
It is important that the Investigator(s) and their relevant personnel are available during 
the monitoring visits and possible audits or inspections and that sufficient time is 
devoted to the process.  
 
INVESTIGATIONAL PRODUCT 
Each red cell collection center and each processing center will be accountable for 
receipt and disposition of all investigational device inventory shipped to the site. All 
investigational devices used to manufacture the study RBC will be stored at the Blood 
Centers, in a secure area with access limited to authorized study personnel. Inventory 
records will be maintained and reviewed according to monitoring procedures. 
An investigational device receiving, and dispensing record will be maintained by the 
Blood Centers to maintain control of investigational devices used during the study. 
Unused Investigational Product (IP), study RBC units, should not be returned to the 
Blood Center, but must be destroyed by the Hospital or Clinic Blood Bank according to 
the Hospital/Institution’s Standard Operating Procedure (SOP). Destruction of any IP 
must be properly documented on the IP Accountability log.  
Any device malfunction will be documented on the eCRFs. If an investigational device 
fails to perform in the expected manner, the Sponsor will be notified, and the event will 
be appropriately reported. If requested, defective devices will be returned to the Sponsor 
for inspection and analysis according to procedures. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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11 
ETHICS 
 
CONDUCT OF THE TRIAL 
The trial will be conducted according to the protocol, the International Council on 
Harmonization E6 Good Clinical Practice (GCP), and applicable local/national 
regulatory requirements and laws.   
 
PATIENT INFORMATION AND CONSENT   
The informed consent/assent form must be agreed to by Cerus and the IRB/IEC and 
must be in compliance with ICH GCP, regional regulatory requirements, and legal 
requirements. 
The Investigator must ensure that each trial patient, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the trial and possible 
risks associated with participation. The Investigator will obtain written informed 
consent/assent from each patient or the patient's legally acceptable representative before 
any trial-specific activity is performed. The informed consent/assent form used in this 
trial, and any changes made during the course of the trial, must be prospectively 
approved by both the IRB/IEC and Cerus before use. The investigator will retain the 
original of each patient's signed consent/assent form. 
 
INSTITUTIONAL REVIEW BOARD (IRB)/ETHICS COMMITTEE (EC) 
This protocol will be submitted to an appropriate central or local IRB/EC and its written 
unconditional approval obtained and submitted to Cerus or its designee before 
enrollment of the first subject. 
Cerus will supply relevant data for Investigators to submit to the IRB/EC for the 
protocol’s review and approval. Written verification of IRB/EC unconditional approval 
of the protocol and the subject Informed Consent Form (ICF)/assent form will be 
transmitted to Cerus or its designee prior to enrolling any subjects in the study. This 
approval must refer to the study by exact protocol title and number (including version), 
identify documents reviewed, and state the date of approval. 
The Investigator must promptly report to the IRB/EC all changes in the research activity 
and all unanticipated problems involving risk to human subjects or others. This includes 
all SAEs that have resulted in an expedited safety report to the regulatory authorities 
(serious, unexpected AEs possibly related to investigational product). Concurrently, the 
Investigator must send the study Sponsor documentation of such IRB/EC notification.  
The Investigator must not make any changes in the research without IRB/EC approval 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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and Cerus approval, except where necessary to eliminate apparent immediate hazards to 
human subjects. 
 
CONFIDENTIALITY 
Individual subject medical information obtained as a result of this study is considered 
confidential, and disclosure to third parties other than those noted below is prohibited. 
Subject confidentiality will be further assured by utilizing subject identification code 
numbers to correspond to treatment data in the computer files. 
However, such medical information may be given to the subject’s personal physician, or 
to other appropriate medical personnel responsible for the subject’s welfare. 
In addition, data generated as a result of this study are to be available for inspection 
upon request by local health authority auditors, the Sponsor (including any person or 
companies that are working for or with or owned by the Sponsor [including monitors 
and auditors]), or by the IRB/EC. Therefore, absolute confidentiality cannot be 
guaranteed. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
Surgery Procedures (the ReCePI study) 
 
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12 
DATA HANDLING AND RECORD KEEPING 
 
CASE REPORT FORMS 
An eCRF is required and should be completed for each included patient. The completed 
original eCRFs are the sole property of Cerus and should not be made available in any 
form to third parties, except for authorized representatives of Cerus or appropriate 
regulatory authorities, without written permission from Cerus. 
It is the investigator's responsibility to ensure completion of, to review, and to approve 
all eCRFs. The eCRFs must be signed by the Investigator or by an authorized staff 
member. These signatures serve to attest that the information contained on the eCRFs is 
true. At all times, the investigator has final personal responsibility for the accuracy and 
authenticity of all clinical and laboratory data entered on the eCRFs. Patient source 
documents are the physician's patient records maintained at the trial site. In most cases, 
the source documents will be the hospital's or the physician's chart. In cases where the 
source documents are the hospital or the physician's chart, the information entered on 
the eCRFs must match those charts.  
In some cases, the eCRF may also serve as the source document. In these cases, Cerus 
and the Investigator must prospectively document which items will be recorded in the 
source documents and for which items the eCRF will stand as the source document. 
 
RECORD RETENTION 
Investigators/institutions and the Sponsor shall maintain all study records required (by 
subpart 21CFR 812.140) during the investigation and for a period of 2 years after the 
latter of the following two dates: the date on which the investigation is terminated or 
completed, or the date that the records are no longer required for purposes of supporting 
a premarket approval application or a notice of completion of a product development 
protocol.  Investigator/institution shall not destroy any such records prior to obtaining 
written permission from Cerus. 
 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac 
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13 
LITERATURE REFERENCES 
1. 
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assay results for predicting the clinical significance of blood group alloantibodies. 
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2. 
Alghamdi AA, Davis A, Brister S et al.  Development and validation of Transfusion Risk 
Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to 
their blood transfusion needs. Transfusion 2006; 46:1120-1129. 
3. 
AuBuchon JP, de Wildt-Eggen J, Dumont LJ, Biomedical Excellence for Safer 
Transfusion C, Transfusion Medicine Resource Committee of the College of American P. 
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2008;132: 1194-201. 
4. 
Bellomo R, Ronco C, Kellum JA, et al: Acute renal failure-Definition, outcome 
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5. 
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D, Lin JS, Wood L, Corash L, Conlan MG.2005. Therapeutic efficacy and safety of red 
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clinical trial in cardiac surgery patients. Transfusion. 2005 Nov;45(11):1739-49. 
6. 
Billings FT, Shaw AD.  2014. Clinical trial endpoints in acute kidney injury.  Nephron 
Clin. Pract. 127(0):89-93. 
7. 
Brecher ME and Hay SN. 2005. Bacterial Contamination of Blood Components. Clin 
Microbiol Rev 18(1), 195-204. 
8. 
Brixner V, Kiessling AH, Madlener K et al. Clinical safety and efficacy of red blood cell 
components treated with the second generation S-303 pathogen and leukocyte 
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(oral presentation) [25th Regional Congress of the International Society of Blood 
Transfusion, 33rd Annual Conference of the British Blood Transfusion Society, London, 
United Kingdom - Jun 27 – Jul 1, 2015] 
9. 
Cancelas J, Gottschall J, Rugg N et al. Red Blood Cells (RBC) Treated with the 
INTERCEPT Pathogen and Leukocyte Inactivation System and Stored for 35 Days 
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American Association of Blood Banks Annual Meeting (AABB) Anaheim, Los Angeles, 
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10. Castro G, Green J, Stassinopoulos A. Effective inactivation of T-cells with S-303/GSH in 
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Vox Sanguinis 2016:111(Suppl. 1) 7-305. 

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11. Chapman JF, Elliott C, et al. 2004. Guidelines for compatibility procedures in blood 
transfusion laboratories. Transfus Med 14(1): 59-73. doi:10.1111/j.0958-
7578.2004.00482.x 
12. Cookson ST, Arduino MJ, Aguero SM, Jarvis WR, and the Yersinia Study Group, 
Program Abstr. 36th Intersci. Conf. Antimicrob. Agents Chemother. abstr. 237, 1996. 
13. Damgaard C, Magnussen K, Enevold C, et al.: Viable bacteria associated with red blood 
cells and plasma in freshly drawn blood donations. PLoS One 2015; 10: e0120826. 
14. Dumont, LJ, and AuBuchon JP. Evaluation of proposed FDA criteria for the evaluation 
of radiolabeled red cell recovery trials. Transfusion 2008; 48(6): 1053-60.  
15. FDA 2016. Recommendations for donor screening, deferral, and product management to 
reduce the risk of transfusion-transmission of Zika virus [Internet]. Silver Spring 
(MD):U.S. Department of Health and Human Services, Food and Drug Administration, 
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16. Garratty G. 2012. What is a Clinically Significant Antibody? ISBT Science Series 7: 54-
57. doi:10.1111/j.1751-2824.2012.01594.x 
17. Hillyer, C., C. Josephson, et al. (2003). Bacterial contamination of blood components: 
risk, strategies, and regulation: Joint ASH and AABB educational session in transfusion 
medicine. Hematology: 575-589. 
18. Hobson, CE, Yavas S, et al. (2009). "Acute kidney injury is associated with increased 
long-term mortality after cardiothoracic surgery." Circulation 119(18): 2444-2453. 
19. Karkouti, K. Transfusion and risk of acute kidney injury in cardiac surgery. Br J Anaesth 
2012; 109 Suppl 1: i29-i38. 
20. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for 
Acute Kidney Injury. Kidney Int Suppl 2012; 2(Suppl 1):8; doi:10.1038/kisup.2012.1 
21. Kleinman S and Stassinopoulos A. Risks associated with red blood cell transfusions: 
potential benefits from application of pathogen inactivation. Transfusion. 2015; 55(12): 
2983-3000. 
22. Kopolovic I, Ostro J, Tsubota H et al. A systematic review of transfusion-associated 
graft-versus- host disease. Blood 2015; 126(3): 406-414. 
23. Kuehnert MJ, Roth VR, Haley NE et al. 2001. Transfusion-transmitted bacterial infection 
in the United States, 1998 through 2000. Transfusion 41:1493-1499. 
24. Lassnigg A, Schmid ER, Hiesmayr M et al. Impact of minimal increases in serum 
creatinine on outcome in patients after cardiothoracic surgery: Do we have to revise 
current definitions of acute renal failure? Crit Care Med 2008; 36:1129-1137 
25. Lassnigg A, Schmidlin D, Mouhieddine M et al.  Minimal changes of serum creatinine 
predict prognosis in patients after cardiothoracic surgery: A prospective cohort study. J 
Am Soc Nephrol 2004; 1597-1605. 

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26. Lee, J. 1999. U.S. Food and Drug Administration. Presented at the FDA/CBER 
Workshop on Bacterial Contamination of Platelets. www.FDA.gov 
27. /CBER/minutes/bact092499.pdf.Levy MM, Fink MP, Marshall JC et al.  
SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions conference.  Critical 
Care Medicine 2003; 31:1250-1256. 
28. Loef, B. G., A. H. Epema, et al. (2005). "Immediate postoperative renal function 
deterioration in cardiac surgical patients predicts in-hospital mortality and long-term 
survival." J Am Soc Nephrol 16(1): 195-200. 
29. MacLennan S and Williamson LM. Risks of fresh frozen plasma and platelets. J Trauma 
2006; 60 (6 Suppl) :S46-50. 
30. Mehta RH, MD, Grab JD, O’Brien SM, Bridges CR, Gammie JS, MD; Haan CK, 
Ferguson TB, Peterson ED, for the Society of Thoracic Surgeons National Cardiac 
Surgery Database Investigators. Bedside Tool for Predicting the Risk of Postoperative 
Dialysis in Patients Undergoing Cardiac Surgery Circulation. 2006;114:2208-2216.  
31. Mehta RL, Kellum JA, Shah SV, et al: Acute Kidney Injury Network: Report of an 
initiative to improve outcomes in acute kidney injury. Crit Care 2007; 11:R31 
32. Murphy GJ, Pike K, Rogers CA, Wordsworth S, Stokes EA, Angelini GD, Reeves BC, 
for the TITRe2 Investigators.  Liberal or Restrictive Transfusion after Cardiac Surgery. N 
Engl J Med 2015; 372:997-1008. 
33. Ness PM, Shirey RS, et al. 1990. The differentiation of delayed serologic and delayed 
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significance. Transfusion 30(8): 688-693. doi:10.1046/j.1537-2995.1990.30891020325.x 
34. O'Neal, J. B., A. D. Shaw, et al. Acute kidney injury following cardiac surgery: current 
understanding and future directions. Crit Care 2016; 20(1): 187 
35. Perez P, Salmi LR, Follea G et al.  2001. Determinants of transfusion-associated bacterial 
contamination: results of the French BACTHEM case-control study.  Transfusion 
41:862-871. 
36. Rico S, North AK, Lin J.S., Mufti N, Corash L. Cumulative Clinical Safety Experience 
In Acute Anemia Transfusion Support With the INTERCEPT System for Red Blood 
Cells (RBC). Vox Sanguinis 2015; 109 (Suppl. 2), 54 (poster P-093) [26th Regional 
Congress of the International Society of Blood Transfusion (ISBT) Bali, Indonesia – 
November 14 – 16, 2015] 
37. SHOT, 2002. Serious Hazards of Transfusion. SHOT report for 2000-2001. Cumulative 
data 01/10/1995-30/09/2001) https://www.shotuk.org/shot-reports/ 
38. Siblini L, Lafeuillade B, Ros A, et al.: Influence of blood prestorage conditions and white 
blood cell filtration on the bacterial load of blood deliberately inoculated with Gram-
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39. Stramer SL, Hollinger FB, et al., Emerging infectious disease agents and their potential 
threat to 2525-2538.transfusion safety. Transfusion 2009;  49 Suppl 2: 1S-29S. 

Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the 
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40. Strobel E. Hemolytic Transfusion Reactions. Transfusion Medicine and Hemotherapy. 
2008;35(5):346-353. doi:10.1159/000154811. 
41. Theakston, E. P., A. J. Morris, S. J. Streat, B. W. Baker, and D. G. Wood- field. 1997. 
Transfusion transmitted Yersinia enterocolitica infection in New Zealand. Aust. N. Z. J. 
Med. 27:62–67T 
42. Thygesen K, Alpert JS and White HD on behalf of the Joint ESC/ACC/AHA/WHF Task 
Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial 
infarction.  European Heart Journal 2007; 28 : 
43. Triulzi D, Kleinman S, Kakaiya R, Busch MP, et al. The effect of previous pregnancy 
and transfusion on HLA alloimmunization in blood donors: implications for a 
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35. 
44. Weisbord SD, Gallagher M, Kaufman J. et al. Prevention of contrast-induced AKI: A 
review of published trials and design of the preservation of serious adverse events 
following angiography (PRESERVE) trial. Clin J Am Soc Nephrol 2013; 8:1618-1631. 
45. Weiskopf RB, Viele MK, Feiner J et al. Human cardiovascular and metabolic response to 
acute, severe isovolemic anemia.  JAMA 1998; 279(3):217-221. 
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criteria for the definition of acute kidney injury in critically ill patients." Int Urol Nephrol 
48(1): 125-132. 
 
 

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14 
APPENDICES 
APPENDIX  1: Transfusion Risk Understanding Scoring Tool (TRUST) 
(Alghamdi AA, Davis A, Brister S, Corey P, Logan A.  Development and validation of 
Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery 
patients according to their blood transfusion needs. Transfusion 2006; 46:1120-1129.) 
Parameter 
Finding 
Points 
 
 
 
Age of the patient in years 
≤ 65 years 
0 
 
> 65 years 
1 
Sex 
male 
0 
 
female 
1 
hemoglobin 
≥ 13.5 g/dL 
0 
 
< 13.5 g/dL 
1 
body weight in kilograms 
≥77 kilograms 
0 
 
< 77 kilograms 
1 
elective surgery 
yes 
0 
 
no (non-elective) 
1 
serum creatinine 
≤ 1.36 mg/dL (120 µmol/L) 
0 
 
> 1.36 mg/dL (120 µmol/L) 
1 
history of previous cardiac surgery 
no 
0 
 
yes 
1 
surgical task 
isolated 
0 
 
Non-isolated (CABG + valve replacement, etc.) 
1 
 
 
 

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Total TRUST Score = SUM (points for all 8 parameters)  
Interpretation: 
 
minimum score: 0 
 
maximum score: 8 
The higher the score the greater the probability of requiring a blood transfusion. 
Total Score 
Risk Group 
Probability of Transfusion 
0 
baseline risk 
< 20% 
1 
low risk 
20 - 39% 
2 
intermediate risk 
40 - 59% 
3 
high risk 
60 - 79% 
4 to 8 
very high risk 
80 - 100% 
 
X = (0.8377 * (total score)) - 1.9503 
Probability of blood transfusion = 1 / (1 + EXP((-1) * X)) 
 
 
 
 

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APPENDIX  2: Evaluation of Reactivity with INTERCEPT RBCs  
 

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1 

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APPENDIX  3 CDC National Healthcare Safety Network Biovigilance Component 
Hemovigilance Module Surveillance Protocol v2.5.2 
 
 
 
 

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Cardiac Surgery Procedures (the ReCePI study) 
 
 
APPENDIX  4: Common Terminology Criteria for Adverse Events (CTCAE) Version 
5.0 Published: November 27, 2017

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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
CONFIDENTIAL AND PROPRIETARY 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Cerus Corporation 
Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
CLI 00125, v8.0 
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Title:  A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the 
INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures (the ReCePI study) 
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