An In Vivo Recovery and Survival Study of Platelets Collected on the Trima Accel System and Stored in InterSol Solution
Phase: NA
Conditions: Healthy Volunteers
Sponsor: Terumo BCT

InterSol In Vivo Platelet Quality Study 
Terumo BCT, Inc. 
Clinical Investigation Plan: CTS-5066 
 
Version 2.0: 10 JUL 2017  
 
Confidential  
Page 1 of 46 
 
CLINICAL INVESTIGATION PLAN 
Study Title: 
An In Vivo Recovery and Survival Study of Platelets Collected on 
the Trima Accel System and Stored in InterSol Solution 
Study Number: 
CTS-5066 
Study Device: 
Trima Accel® Apheresis system and InterSol Solution 
Manufacturer: 
Terumo BCT, Inc. 
10811 West Collins Avenue 
Lakewood, CO 80214 USA 
Phone: (303) 231-4832 
Sponsor: 
Terumo BCT, Inc. 
10811 West Collins Avenue 
Lakewood, CO 80214 USA 
Phone: (303) 231-4832 
Contact: 
Heather Pidcoke, MD, PhD 
Phone: (303) 231-4832 
Email: Heather.Pidcoke@terumobct.com  
This study will be conducted according to this Clinical Investigation Plan, Good Clinical Practice 
as described in the International Conference of Harmonisation Guidance for Industry E6, and as 
applicable, United States Food and Drug Administration 21 CFR 600-680 and 21 CFR 812, 
International Organization for Standardization 14145:2011(E), and other regulatory requirements 
of the regions where the study is conducted. All essential documents will be archived. 
 
Version/Date: 2.0/10 JUL 2017 
 
Confidentiality Statement 
The information contained in this document, particularly unpublished data, is the property or 
under control of the Sponsor, and is provided to you in confidence as an Investigator, potential 
Investigator, or consultant, for review by you, your staff, and an applicable Institutional Review 
Board/Ethics Committee. The information is only to be used by you in connection with 
authorized clinical studies of the investigational device described in the Clinical Investigation 
Plan. You will not disclose any of the information to others without written authorization from 
the Sponsor except to the extent necessary to obtain informed consent from those persons who 
may participate in the clinical trial. Please refer to the applicable Master and/or Clinical Trial 
Agreement for complete details regarding applicable confidentiality standards. 
 

InterSol In Vivo Platelet Quality Study 
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Clinical Investigation Plan: CTS-5066 
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AMENDMENT 1 SUMMARY OF CHANGES 
Study Title: 
An In Vivo Recovery and Survival Study of Platelets Collected on the Trima 
Accel System and Stored in InterSol Solution 
CIP #: 
CTS-5066 
Amendment Version / Date: 
Version 2.0/10 JUL 2017 
Replaces CIP Version / Date: 
Version 1.0/27 FEB 2017 
Rationale: 
This CIP was updated to clarify that participants are not allowed to take aspirin 
or aspirin containing medications, non steroidal anti inflammatory drugs 
(NSAIDs), anti-platelet agents, or other drugs affecting platelet viability for the 
duration of the study. Because the study’s primary endpoints relate to platelet 
survival and recovery, this clarification is necessary to ensure the platelets being 
evaluated are not exposed to drugs affecting their viability throughout the study. 
Additionally, this amendment ensures participants are aware that they are not 
permitted to take these medications, and if they do, they will be discontinued 
from the study. The inclusion criteria, study procedures, and reason for study 
procedure discontinuation/termination were updated to better clarify this 
requirement. 
 
Additionally, this CIP amendment addresses a minor typographical error noted 
by the United States Food and Drug Administration (FDA) in the section of the 
CIP outlining the number of participants. The CIP incorrectly stated “an 
approximate 45% screen fail/early termination rate which would allow up to 40 
healthy adult participants to be enrolled in this study”. Applying a 45% screen 
fail/early termination rate would result in total enrollment of 44 subjects. This 
study will only enroll up to 40 healthy adult participants, therefore the 
approximate screen fail/early termination rate was changed from 45% to 40%. 
 
Administrative changes, typographical error corrections, abbreviations and 
minor wording changes for clarity have been made and will not be reflected in 
the table below. 
Section(s) 
Used to Read: 
Now Reads: 
Synopsis,  Section 10.1 
Number of Participants and 
Selection, and Section 16.1 
Sample Size 
Assuming an approximate 45% 
screen fail/early termination rate, 
up to 40 healthy adult participants 
will be enrolled in this study to 
ensure 24 evaluable data points 
across 2 investigational sites in the 
United States. 
Assuming an approximate 40% screen 
fail/early termination rate, up to 40 healthy 
adult participants will be enrolled in this 
study to ensure 24 evaluable data points 
across 2 investigational sites in the United 
States. 
Synopsis and Section 10.2 
Inclusion Criteria 
Has been added 
8. Participants must agree to refrain 
from using aspirin or aspirin containing 
medications, non steroidal anti 
inflammatory drugs (NSAIDs), anti-
platelet agents, or other drugs affecting 
platelet viability for the duration of the 
study 

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Table 11-1 in Section 11 
Study Procedures 
Confirm participant is healthy and 
did not take any exclusionary 
medications on Apheresis Visit 
and Infusion Day 
Confirm participant is healthy on 
Apheresis Visit and Infusion Day 
Record any medications taken in the 7 
days prior to apheresis procedure and 
through study completion on Apheresis 
Visit, Infusion Day, and Post-Infusion 
Days 
Confirm participant is healthy and did not 
take any exclusionary medicationb on 
Apheresis Visit, Infusion Day, and Post-
Infusion Days 
Record medications medical 
interventions to treat any AEs or SAEs 
b Exclusionary medication includes 
aspirin or aspirin containing 
medications, NSAIDs, anti-platelet 
agents, or other drugs affecting platelet 
viability. 
Section 11.2.1 Prior to 
Apheresis Visit  
1.  Confirm participant is healthy 
and did not take any excludable 
medication if screening visit was 
prior to apheresis visit 
1. Confirm participant is healthy  
2. Record any medications taken in the 7 
days prior to the Apheresis Visit and 
during this visit.  
3. Confirm the participant did not take 
any excludable medication (see Section 
13) if screening visit was prior to apheresis 
visit 
Section 11.2.2 Apheresis 
Procedure; Section 11.4 
Infusion Day; Section 11.5.1 
Post Infusion Days 6-12 
(BEST Days 1-7); 
Section 11.5.2 Post Infusion 
Day 16 ± 1 day (BEST Day 11 
± 1 day) 
Record medications or medical 
interventions to treat AEs or SAEs 
Record medications or medical 
interventions to treat AEs or SAEs 
Section 11.4 Infusion Day; 
Section 11.5.1 Post Infusion 
Days 6-12 (BEST Days 1-7); 
Section 11.5.2 Study Day 
16±1 day (BEST Day 11±1 
day) 
Has been added 
2. Record any concomitant medications 
taken since previous visit and during 
this visit 
Section 11.5.1 Study Days 6-
12 (BEST Days 1-7) and  
Section 11.5.2 Study Day16 ± 
1 day (BEST Day 11 ± 1 day) 
Has been added 
1. Confirm participant did not take any 
exclusionary medication since previous 
visit 
Section 11.5.1 Study Days 6-
12 (BEST Days 1-7) 
Has been added 
2. Record any concomitant medications 
taken since previous visit and during 
these visits 

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Section 11.6 Study Procedure 
Discontinuation/Termination 
Has been added 
17. Participant took exclusionary 
medication (see Section 13) 
Section 13 Concomitant 
Medications 
Only medications administered to 
treat AEs or SAEs will be 
recorded in the eCRFs. 
Participants are prohibited from taking 
aspirin or aspirin containing 
medications for 7 days prior to the 
apheresis procedure, and NSAIDs, anti-
platelet agents, or other drugs affecting 
platelet viability for 3 days prior to the 
apheresis procedure.  Once enrolled in 
the study, participants are prohibited 
from taking these medications 
throughout their participation in the 
study.   
Concomitant medications taken from 
the 7 days before the apheresis visit 
until study exit will be recorded in the 
eCRFs. 
Medical interventions administered to 
treat AEs or SAEs will be recorded in the 
eCRFs. 

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SYNOPSIS 
Sponsor: 
Terumo BCT, Inc. 
Study Title: 
An In Vivo Recovery and Survival Study of Platelets Collected on the Trima Accel 
System and Stored in InterSol Solution 
Study Number: 
CTS-5066 
Target Population: 
Healthy Adult Volunteer Donors 
Device Description: 
The Trima Accel® Automated Blood Collection system (Trima Accel system) is an 
automated blood component collection system that uses centrifugal force to separate 
donor blood into platelet, plasma, and red blood cell (RBC) components and uses Acid 
Citrate Dextrose, Formula A (ACD-A) as the anticoagulant. The device is comprised 
of 3 major sub-systems: 1) the Trima machine itself; 2) sterile, single use disposable 
blood tubing sets; and 3) embedded software. There are additional optional accessories 
such as plasma bag, platelet bag, seal safe system, and barcode scanner kit.  
Terumo BCT’s Trima Accel system received United States Food and Drug 
Administration (FDA) 510(k) clearance for hyperconcentrated platelet collections on 
17 December 2012 (BK120049).  
Fenwal’s InterSol® was cleared by the FDA on 09 December 2009 (BN080041), as a 
platelet additive solution (PAS) for the replacement of 65% plasma in platelet 
components for use with Amicus™ Separator System. 
Intended Use: 
The intended use for the Trima Accel system and PAS (InterSol) combination to be 
evaluated in this investigational study is to use the Trima Accel system to collect 
platelet concentrates from normal healthy donors and to re-suspend the platelets in 
35% plasma and 65% InterSol for storage and subsequent transfusion into patients 
requiring blood product support. 
Study Centers Planned: 
2 centers in the United States. 
Objective: 
The primary objective of this study is to determine the in vivo recovery and survival of 
radiolabeled platelets collected on the Trima Accel system, diluted in 65% 
InterSol/35% plasma, and stored for 5 days.  
Efficacy Endpoints: 
Primary Efficacy Endpoints: 
The primary endpoint for this study will be recovery and survival as calculated using 
the COST software.  
1. For recovery: Test – 0.66*Control ≥ 0 with a 1 sided 97.5% confidence limit 
2. For survival: Test – 0.58*Control ≥ 0 with a 1 sided 97.5% confidence limit 
Safety Endpoints: 
Safety will be monitored through the collection of adverse events (AEs), serious 
adverse events (SAEs), and unanticipated adverse device effects (UADEs) from the 
start of the apheresis procedure venipuncture until study completion. Products will be 
destroyed per the site’s standard operating procedures (SOPs) after all testing has been 
completed. 

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Inclusion Criteria: 
1. Age 18 years or older 
2. Normal health status as per AABB criteria for healthy donor 
3. Able to commit to the study schedule 
4. Meets the inclusion criteria defined by the Blood Center for apheresis platelet with 
PAS collection on the Trima Accel system. These criteria are based on FDA 
Regulations and AABB standards. Note: Participants who are deferred from 
volunteer community donations because of travel restrictions, piercings, or tattoos 
may participate in the study, as products are not transfused 
5. Participants of child-bearing potential (either male or female) must agree to use an 
effective method of contraception during the course of the study 
6. Females of childbearing potential must be willing to take a pregnancy test prior to 
infusion of radiolabeled platelets 
7. Has given written informed consent        
8. Participant must agree to refrain from using aspirin or aspirin containing 
medications, non steroidal anti inflammatory drugs (NSAIDs), anti-platelet agents, 
or other drugs affecting platelet viability for the duration of the study 
Exclusion Criteria: 
1. Previously received radiation therapy 
2. Has been diagnosed with a platelet disorder (ie, platelet dysfunction) 
3. Already participated in 4 research studies involving radioisotopes within the 
contemporaneous calendar-year 
4. Pregnant or nursing females 
5. Participation currently, or within the last 12 months, in another investigational trial 
that would potentially interfere with the analysis of this investigation 
6. History of known hypersensitivity to indium or chromium 
7. Treatment with aspirin or aspirin containing  medications within 7 days of apheresis 
or treatment with NSAIDs, anti-platelet agents or other drugs affecting platelet 
viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs) 
Number of Participants  
Planned: 
Assuming an approximate 40% screen fail/early termination rate, up to 40 healthy 
adult participants will be enrolled in this study to ensure 24 evaluable data points 
across 2 investigational sites in the United States. 

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Clinical Investigation Plan: CTS-5066 
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Study Design: 
This is a prospective, open-label, multicenter, controlled study to evaluate in vivo 
recovery and survival of radiolabeled apheresis platelets collected on the Trima Accel 
system and stored in 65% InterSol/35% plasma for 5 days. 
One (1) Test unit will be collected as a hyperconcentrated platelet product. The Test 
unit will be diluted to a final ratio of 65% InterSol/35% plasma. 
After collection, the Test unit will be stored at room temperature with agitation for 
5 days.  
On Day 5, study sites will follow the “Platelet Radiolabeling Procedure” published by 
Biomedical Excellence for Safer Transfusion (BEST) and their SOPs for platelet 
radiolabeling, infusion, radioactivity sampling, and recovery and survival calculations. 
Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with 
either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a 
whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not 
used in the Test platelets. The identity of the label (51Cr or 111In) used for Test and 
Control platelets will be randomized. The labeled aliquots will then be infused 
simultaneously on Day 5 (BEST Day 0) back to the autologous donor. On Study Day 5 
(BEST Day 0) samples will be drawn at 0 (pre-infusion) and 2 hours ± 15 minutes 
post-infusion. Next, 1 sample will be drawn daily (except on weekends) from Study 
Day 6 through Day 12 (BEST Day 1  ̶  7) for a total of 5 samples. To conclude, 1 final 
sample will be drawn on Study Day 15, 16, or 17 (BEST Day 10, 11, or 12). Recovery 
and survival will be calculated at each site according to the COST software. 
Study Duration: 
Study participation will be up to 9 visits. Screening may be done within 5 days prior to 
the apheresis procedure or combined as 1 visit, which includes screening and the 
apheresis procedure all in 1 day.  
The entire study is anticipated to last approximately 5 months. 
Statistical 
Methodology: 
Primary Endpoints: 
The primary endpoints of this study are to show that recovery and survival of platelets 
collected on the Trima Accel system, diluted in 65% InterSol/35% plasma and stored 
for 5 days meet FDA standards defined by: 
• For recovery: Test – 0.66*Control ≥ 0 with a 1-sided 97.5% confidence limit 
• For survival: Test – 0.58*Control ≥ 0 with a 1-sided 97.5% confidence limit 
Recovery (at 24 hours) is expressed as a percentage of the extrapolated platelet count 
at time 0. Survival is expressed in hours and is approximated using linear regression. 
For each endpoint, paired differences within each participant will be used to construct 
the lower limit of a 1-sided 97.5% confidence intervals. If the lower limit is greater 
than 0 for both endpoints, the test product will be declared to meet the FDA standard.  
 

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TABLE OF CONTENTS 
1 
INTRODUCTION......................................................................................................14 
1.1 
Background ......................................................................................................14 
2 
DEVICE DESCRIPTION .........................................................................................14 
2.1 
Trima Accel System Device Description .........................................................14 
2.2 
InterSol Solution ..............................................................................................16 
3 
INTENDED USE STATEMENT .............................................................................17 
4 
CLINICAL STUDY EXPERIENCE ........................................................................17 
5 
RATIONALE FOR THE CURRENT STUDY .......................................................18 
6 
OBJECTIVE ..............................................................................................................18 
7 
EFFICACY ENDPOINTS.........................................................................................18 
7.1 
Primary Efficacy Endpoints .............................................................................18 
8 
SAFETY ENDPOINTS .............................................................................................19 
9 
INVESTIGATIONAL PLAN ...................................................................................19 
9.1 
Study Design ....................................................................................................19 
9.2 
Study Duration .................................................................................................21 
10 
STUDY POPULATION ............................................................................................21 
10.1 
Number of Participants and Selection ..............................................................21 
10.2 
Inclusion Criteria .............................................................................................21 
10.3 
Exclusion Criteria ............................................................................................22 
10.4 
Enrollment........................................................................................................22 
11 
STUDY PROCEDURES ...........................................................................................23 
11.1 
Screening Visit: Study Days -5 to 0 .................................................................26 
11.2 
Apheresis Visit: Study Day 0 ...........................................................................26 
11.2.1 
Prior to Apheresis .............................................................................26 
11.2.2 
Apheresis Procedure .........................................................................26 
11.3 
Post Collection Handling: Study Days 0 - 5 ....................................................27 
11.4 
Infusion Day: Study Day 5 (BEST Day 0) ......................................................27 
11.5 
Post-Infusion Days ...........................................................................................28 
11.5.1 
Study Days 6-12 (BEST Days 1-7) ...................................................28 
11.5.2 
Study Day 16 ± 1 day (BEST Day 11 ± 1 day) ................................28 
11.6 
Study Procedure Discontinuation/Termination................................................29 

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11.7 
Stopping Rules .................................................................................................30 
12 
LABORATORY TESTS ...........................................................................................30 
12.1 
Clinical Laboratory Tests .................................................................................30 
12.2 
Test Product Laboratory Test ...........................................................................30 
12.3 
Platelet Radiolabeling Procedures ...................................................................30 
13 
CONCOMITANT MEDICATIONS ........................................................................30 
14 
ADVERSE EVENTS/EFFECTS ..............................................................................31 
14.1 
Anticipated Risks .............................................................................................31 
14.1.1 
Venipuncture Related........................................................................31 
14.1.2 
Apheresis Complications in Healthy Donors ....................................31 
14.1.3 
Apheresis Risks with the Trima Accel System .................................33 
14.1.4 
Potential Risks of Infusion of Radiolabeled Platelets .......................33 
14.2 
Risk Mitigation ................................................................................................33 
14.3 
Adverse Event Definitions ...............................................................................34 
14.4 
Adverse Event Recording ................................................................................34 
14.5 
Adverse Event Reporting .................................................................................34 
14.5.1 
Severity .............................................................................................34 
14.5.2 
Relationship ......................................................................................34 
14.6 
Adverse Event Follow-up ................................................................................35 
14.7 
Serious Adverse Events and Unanticipated Adverse Device Effect ................35 
14.7.1 
Definition ..........................................................................................35 
14.7.2 
SAE/UADE Reporting ......................................................................36 
14.8 
Clinical Investigation Plan Deviations .............................................................37 
14.9 
Medical Monitoring .........................................................................................37 
15 
STUDY DEVICE .......................................................................................................37 
15.1 
Device Deficiencies .........................................................................................37 
15.2 
Device Accountability .....................................................................................37 
15.2.1 
Receipt of Study Device ...................................................................37 
15.2.2 
Storage ..............................................................................................38 
15.2.3 
Accountability ...................................................................................38 
16 
STATISTICAL PLAN ...............................................................................................38 
16.1 
Sample Size ......................................................................................................38 
16.2 
Outcome Measures...........................................................................................38 

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16.2.1 
Primary Endpoint ..............................................................................38 
16.2.2 
Safety Measures ................................................................................39 
16.3 
Analysis Population .........................................................................................39 
16.4 
CIP Analysis Exclusions ..................................................................................39 
17 
STUDY MANAGEMENT .........................................................................................40 
17.1 
Investigator Responsibilities ............................................................................40 
17.1.1 
Investigator Agreement .....................................................................40 
17.1.2 
Institutional Review Board ...............................................................40 
17.1.3 
Informed Consent..............................................................................40 
17.1.4 
Study Files and Record Retention.....................................................41 
17.1.5 
Regulatory Compliance ....................................................................41 
17.2 
Sponsor Responsibilities ..................................................................................41 
17.2.1 
Amendments to the CIP ....................................................................41 
17.2.2 
General Responsibilities ...................................................................41 
17.3 
Joint Investigator-Sponsor Responsibilities .....................................................41 
17.3.1 
Training .............................................................................................41 
17.4 
Collecting and Recording Data ........................................................................41 
17.4.1 
Source Documents ............................................................................42 
17.4.2 
Case Report Forms ............................................................................42 
17.5 
CIP Compliance ...............................................................................................42 
17.6 
Termination of the Study .................................................................................42 
17.7 
Publication Policy ............................................................................................42 
18 
REFERENCES ...........................................................................................................44 
 
List of Tables 
Table 11-1: 
List of Study Procedures ..................................................................................24 
Table 14-1: 
Venipuncture Adverse Event Frequency .........................................................31 
Table 14-2: 
Apheresis Adverse Event Frequency ...............................................................32 
 
List of Figures 
Figure 2-1: 
Components of the Trima Accel System .........................................................16 
Figure 9-1: 
Study Design ....................................................................................................20 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
111In 
Indium 111 
51Cr 
Chromium 51 
ACD-A 
Anticoagulant Citrate Dextrose, Solution A 
AE 
Adverse Event 
BEST 
Biomedical Excellence for Safer Transfusion 
CBC 
Complete Blood Count 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CTA 
Clinical Trial Agreement 
CTCAE 
Common Terminology Criteria for Adverse Events 
DVT 
Deep Vein Thrombosis 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EDTA 
Ethylenediaminetetraacetic Acid 
ESC 
Extent of Shape Change 
FAS 
Full Analysis Set 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice 
HCT 
Hematocrit 
HCO3 
Bicarbonate 
Hgb 
Hemoglobin 
HSR 
Hypotonic Shock Response 
IC 
Informed Consent 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation  
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
IV 
Intravenous 
LDH 
Lactate Dehydrogenase 
LOC 
Loss of Consciousness 
MedDRA 
Medical Dictionary For Regulatory Activities 
MOP 
mg 
Manual of Procedures 
Milligram(s) 
mL 
Milliliter(s) 
NSAID 
Non-steroidal Anti-inflammatory Drugs 
PAS 
Platelet Additive Solution 
pCO2 
Partial Pressure of Carbon Dioxide 

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PHI 
Protected Health Information 
pO2 
Partial Pressure of Oxygen 
PVC 
Polyvinyl Chloride 
RBC 
Red Blood Cell 
SAE 
Serious Adverse Event 
SD 
Source Documents 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
USID 
Unique Study Identification  
USP 
United States Pharmacopeia 
WBC 
White Blood Cell 
 
 
 
 

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1 
INTRODUCTION 
1.1 
Background 
Platelet transfusions are used extensively for the treatment and prophylaxis of bleeding 
associated with major trauma, surgery, chemotherapy, and in thrombocytopenic individuals (have 
low platelet count) as well as those with platelet dysfunctions. The platelets used for platelet 
transfusions are separated from donor blood through either whole blood collections or advanced 
apheresis techniques. In the United States, the majority of platelets used for transfusion are 
routinely collected and stored in 100% donor plasma.  
In Europe it is common practice to replace part of the storage plasma with a platelet additive 
solution (PAS). The rationale behind this is that diluting the plasma with PAS may reduce the 
risk of deleterious reactions such as allergic reactions because there are fewer cellular mediators 
present than found in 100% plasma.1 Substituting PAS for plasma may have other advantages as 
well. Platelet additive solutions have a more consistent composition than plasma from different 
donors, can be optimized for longer storage, and allow for a more frugal use of blood 
components since more plasma can then be used for other applications instead of platelet 
storage.2,3 
Platelet additive solutions have been used for over 20 years in Europe. In the United States, the 
first Food and Drug Administration (FDA) approval for the use of PAS was in 2009. This first 
approval was for the use of the InterSol Solution (a PAS-E) as a replacement of 65% plasma in 
platelet components. A second PAS, IsoplateTM Solution (a PAS-F), has since been cleared by the 
FDA (March 5, 2015, BN090067/0). In Europe, platelet additive solutions and apheresis devices 
are approved separately, but in the United States the use of a PAS is linked to the specific 
apheresis device used to obtain the platelets. The Isoplate Solution is approved for use with the 
Trima Accel® Automated Blood Collection System (Trima Accel system) and the InterSol 
Solution (hereon referred to as InterSol) is approved for use with the AmicusTM Separator System 
(Amicus). 
Terumo BCT is pursuing FDA clearance for InterSol in combination with the Trima Accel 
system in order to provide blood centers with the option to use InterSol as well as Isoplate 
Solution when collecting platelets to be stored in a PAS.  
2 
DEVICE DESCRIPTION 
2.1 
Trima Accel System Device Description 
The Trima Accel system is an automated blood component collection system that uses 
centrifugal force to separate whole blood into platelet, plasma, and red blood cell (RBC) 

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components. These blood components are either collected into storage bags, or returned to the 
donor. The Trima Accel system consists of: 
• The Trima Accel machine 
• Embedded software 
• Disposable tubing sets 
• Optional accessories, connected to the system which can include: 
o Accessory storage plasma bag 
o Accessory storage platelet bag 
o Trima Accel seal safe system 
o Trima barcode scanner kit 
The products collected depend on the disposable tubing collection set used, the donor specific 
parameters (donor’s total blood volume, hematocrit [HCT] or hemoglobin [Hgb], and platelet 
count) entered at the time of collection, and the procedure selected. Donor blood type may also 
be used to limit which blood components are collected.  
The current Trima Accel system equipment is approximately 42 inches tall and 21 inches wide, 
and weighs less than 200 pounds. The Trima Accel system uses disposable tubing sets with a 
cassette that automatically loads the tubing into the pumps, valves, and sensors. The touch screen 
display is designed to lead the operator through the setup and operating procedures, and provide 
detailed messages to assist in troubleshooting the collection procedures. 
Figure 2-1 identifies the major components of the Trima Accel system. 

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Figure 2-1: 
Components of the Trima Accel System 
 
a. 
The IV pole is a metal tube with an arm that 
contains hooks for hanging the product bags. 
The pole is lowered for transport.  
b. The product bags are part of the disposable 
tubing set. Product bags hold the collected 
RBCs, platelets, and plasma.  
c. 
The touch-screen display is the screen that is 
used to monitor and control the blood 
collection procedure. Throughout the 
procedure, the display guides the operator 
from step to step. 
d. The cassette is part of the disposable tubing 
set that snaps into place on the front of the 
system. The cassette guides the flow of 
blood and blood products through the 
system. It also ensures that the tubing is 
positioned so that the pumps, valves, and 
sensors are loaded automatically.  
e. 
The 5 pumps are the components that push 
the blood and products through the system. 
f. 
The filler is designed with a groove in which 
the channel is loaded. The filler comprises 
the top portion of the centrifuge.  
g. The centrifuge is a rotating device that spins 
at up to 3,000 rpm, creating a gravitational 
force to separate the whole blood into its 
components. 
h. The wheels can be locked in position to 
stabilize the Trima Accel system during a 
collection procedure or unlocked to easily 
move the Trima Accel system to a new 
location. 
The Trima Accel system was cleared by FDA for the collection of hyperconcentrated platelets 
stored in Isoplate (BK120049) on 17 December 2012. There will be no modification to the Trima 
Accel device for this study and it will be used as described in the Trima Accel Operator’s 
Manual.  
The Trima Accel Platelet + Sampler + AutoPAS MultiPlasma, RBC disposable set was cleared 
by the FDA (BK120049) on 17 December 2012. This disposable set will be used for the 
collection of hyperconcentrated platelets in this study as described in the Trima Accel Operator’s 
Manual.  
2.2 
InterSol Solution  
InterSol, from Fenwal™, a Fresenius Kabi company, was FDA approved for the storage of 
hyperconcentrated platelets (BN080041) on 09 December 2009. InterSol is an isotonic solution 

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designed to replace a proportion of the plasma used in the storage of Amicus derived 
leukoreduced apheresis platelets under standard blood banking conditions. 
The solution contains: sodium acetate as a nutrient, sodium citrate to prevent platelet clumping 
and activation, sodium phosphate for buffering, and sodium chloride for osmolarity. InterSol 
does not have a pharmacological effect in vivo, but rather acts to provide the appropriate 
environment for platelet storage in lieu of a portion of the plasma normally used. 
InterSol is provided as a 500 mL sterile and non-pyrogenic solution in a non-citrated polyvinyl 
chloride (PVC) plastic container with a sterile and non-pyrogenic fluid path. 
Each 100 mL contains 305 mg Dibasic Sodium Phosphate, Anhydrous, United States 
Pharmacopeia (USP); 93 mg Monobasic Sodium Phosphate, Monohydrate, USP; 318 mg 
Sodium Citrate, Dihydrate, USP; 442 mg Sodium Acetate, Trihydrate, USP; 452 mg Sodium 
Chloride, USP; Water for Injection, USP quantity sufficient.4 
3 
INTENDED USE STATEMENT 
The intended use for the Trima Accel system and PAS (InterSol) combination to be evaluated in 
this investigational study is to use the Trima Accel system to collect platelet concentrates from 
normal donors and to re-suspend the platelets in 35% plasma/65% InterSol for storage and 
subsequent transfusion into patients requiring blood product support. 
4 
CLINICAL STUDY EXPERIENCE 
A randomized, paired, prospective, open-label, multicenter, controlled study was conducted in 
2016 to evaluate the in vitro quality of platelets collected on the Trima Accel system and stored 
for up to 7 days in 65% InterSol/35% plasma (Test) compared to platelets stored in 100% plasma 
(Control). All the Test products had a pH ≥ 6.2 after 5 and 7 days of storage and thus met the 
FDA acceptance criteria for pH.5,6 
Secondary endpoint analyses of partial pressure of oxygen (pO2), partial pressure of carbon 
dioxide (pCO2), bicarbonate (HCO3
-), lactate, glucose, lactate dehydrogenase (LDH), extent of 
shape change (ESC), hypotonic shock response (HSR), morphology, and P-selectin were 
performed after storage of the products for 5 and 7 days. Of these secondary endpoints, only 
ESC, HSR, morphology, and P-selectin had established acceptance criteria. Morphology met the 
established acceptance criteria but ESC, HSR, and P-selectin values did not. The results from this 
study of Trima Accel collected platelets stored in InterSol are consistent with results of similar 
studies evaluating Amicus collected platelets stored in InterSol.6,7 

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5 
RATIONALE FOR THE CURRENT STUDY 
This is a prospective, open-label, multicenter, controlled study to evaluate the in vivo platelet  
recovery and survival of hyperconcentrated platelets collected on the Trima Accel system and 
stored for 5 days in InterSol. In order to promote better standardization among the industry for 
determining the safety and effectiveness of different platelets products (ie, different collection 
methods, different processing procedures, and/or different storage conditions), the FDA has 
issued guidance outlining the appropriate study design for in vivo platelet evaluation.8 This 
guidance recommends the radiolabeling of both stored (Test) and fresh (Control) platelets and 
their autologous reinfusion for the determination of recovery and survival.8 Using these 
recommendations, the Biomedical Excellence for Safer Transfusion (BEST) Collaborative 
generated a platelet radiolabeling protocol that provides a detailed procedure for the generation, 
infusion, timing of blood draws, and calculations needed to determine the platelet recovery and 
survival of new platelet products.9  
Using the BEST Collaborative protocol, this study will determine the recovery and survival of 
5 day platelets stored in 65% InterSol/35% plasma. Specifically, a single hyperconcentrated 
platelet unit will be collected on the Trima Accel system, diluted with 65% InterSol/35% plasma, 
and stored at room temperature with agitation for 5 days (Test). On Study Day 5, the Test 
platelets will be radiolabeled with either Indium 111 (111In) or Chromium 51 (51Cr) according to 
a predetermined randomization scheme and their recovery and survival will be compared to fresh 
platelets (Control) radiolabeled with the other radioisotope (111In or 51Cr).  The recovery and 
survival of Test platelets will be calculated at each site according to the COST software. 
6 
OBJECTIVE 
The primary objective of this study is to determine the in vivo recovery and survival of 
radiolabeled platelets collected on the Trima Accel system, diluted in InterSol, and stored for 
5 days. 
7 
EFFICACY ENDPOINTS 
7.1 
Primary Efficacy Endpoints 
The primary endpoint for this study will be the recovery and survival of platelets as calculated 
using the COST software. Recovery (at 24 hours) is expressed as a percentage of the 
extrapolated platelet count at time 0. Survival is expressed in hours and is approximated using 
linear regression. 
1. In vivo radiolabeled platelet recovery > 66% 
2. In vivo radiolabeled platelet survival > 58%  

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For each endpoint, paired differences within each participant will be used to construct the lower 
limit of a 1-sided 97.5% confidence interval. If the lower limit is greater than 0 for both 
endpoints, the test product will be declared to meet the FDA criteria. 
8 
SAFETY ENDPOINTS 
Safety will be monitored through the collection of adverse events (AEs), serious adverse events 
(SAEs), and unanticipated adverse device effects (UADEs) from the start of the apheresis 
procedure venipuncture until study completion.  
9 
INVESTIGATIONAL PLAN 
9.1 
Study Design 
This is a prospective, open-label, multicenter, controlled study to determine the in vivo recovery 
and survival of radiolabeled hyperconcentrated platelets collected on the Trima Accel system and 
stored for 5 days in 65% InterSol/35% plasma. An outline of the full study design is provided in 
Figure 9-1. 

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randomization scheme provided to each site from the Sponsor. After infusion with the 
radiolabeled Test and Control platelets, blood samples for radioactivity measurements and the 
calculations to determine platelet recovery and survival will be conducted by the sites as outlined 
in the BEST Collaborative.9 Recovery and survival will be calculated at each site according to 
the COST software. 
9.2 
Study Duration 
Study participation will be up to 9 visits. Screening may be done within 5 days prior to the 
apheresis procedure or combined as 1 visit, which includes screening and the apheresis 
procedure all in 1 day. The apheresis procedure can last from 25 to 150 minutes, depending on 
the machine configuration, participant parameters, the quality of the vascular access, and the 
tolerance of the participant to the Anticoagulant Citrate Dextrose, Solution A (ACD-A).  
After the apheresis collection, participants will be asked to return to the site 5 days later for the 
collection of fresh (Control) platelets and to be infused with an aliquot of the radiolabeled Test 
and Control platelets. Participants will then return to the site for whole blood sample collections 
as described in Section 11.  
The entire study is anticipated to last approximately 5 months. 
10 
STUDY POPULATION 
10.1 
Number of Participants and Selection 
Assuming an approximate 40% screen fail/early termination rate, up to 40 healthy adult 
participants will be enrolled in this study to ensure 24 evaluable data points across 
2 investigational sites in the United States.  
Donors will be selected from the community donor and/or research pool and will be 
representative of the healthy adult volunteer population. Participants will be recruited in a 
non-coercive manner and recruitment will be irrespective of ethnicity or gender. 
10.2 
Inclusion Criteria 
1. Age 18 years or older 
2. Normal health status as per AABB criteria for a healthy donor 
3. Able to commit to the study schedule 

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4. Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with 
PAS collection on the Trima Accel system. These criteria are based on FDA Regulations 
and AABB standards. Note: Participants who are deferred from volunteer community 
donations because of travel restrictions, piercings, or tattoos may participate in the study, 
as products are not transfused 
5. Participants of child-bearing potential (either male or female) must agree to use an 
effective method of contraception during the course of the study  
6. Female of childbearing potential must be willing to take a pregnancy test prior to infusion 
of radiolabeled platelets 
7. Has given written informed consent 
8. Participants must agree to refrain from using aspirin or aspirin containing medications, 
non steroidal anti inflammatory drugs (NSAIDs), anti-platelet agents, or other drugs 
affecting platelet viability for the duration of the study 
10.3 
Exclusion Criteria 
1. Previously received radiation therapy 
2. Has been diagnosed with a platelet disorder (ie, platelet dysfunction) 
3. Already participated in 4 research studies involving radioisotopes within the 
contemporaneous calendar-year 
4. Pregnant or nursing females 
5. Participation currently, or within the last 12 months, in another investigational trial that 
would potentially interfere with the analysis of this investigation 
6. History of known hypersensitivity to indium or chromium 
7. Treatment with aspirin or aspirin containing  medications within 7 days of apheresis or 
treatment with NSAIDs, anti-platelet agents or other drugs affecting platelet viability 
within 3 days of apheresis (eg, ibuprofen or other NSAIDs) 
10.4 
Enrollment 
A donor is considered to be an enrolled participant following informed consent. It is expected 
that due to the screening and eligibility requirements, some fraction of participants will not 
qualify for a platelet donation after consent and some who are enrolled may not complete all of 
their anticipated procedures. Participants will be considered screen failures if they fail to meet 
any of the eligibility criteria after signing informed consent. Participants who do not have a 
complete donation (donor receives rinseback, there was automated addition of PAS, and final 
platelet product has a platelet yield ≥ 3.0 × 1011 and ≤ 5.1 × 1011)  or do not return for the 
recovery and survival sample collections per BEST Collaborative will be considered an early 
termination. 

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After informed consent has been obtained, participants will receive a unique study identification 
(USID) number. The USID number will use the following convention: XX-YYY, where XX is 
the pre-assigned site number and YYY will be a sequential number starting with 001. The USID 
number will be recorded on the electronic Case Report Form (eCRF).   
Participants that fail screening criteria on information or laboratory values that are anticipated to 
change, may be rescreened. Participants that are an early termination or donated a product that 
meets any of the protocol analysis exclusions (Section 16.4) may rescreen as long as they were 
not infused with a radiolabeled product and will meet all the inclusion criteria when they return. 
Participants that are rescreened will be assigned a new USID number. 
11 
STUDY PROCEDURES 
A summary of study procedures is provided in Table 11-1. 
 
 

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Table 11-1: 
List of Study Procedures 
 
Screening  
Visit 
 (Day -5 – Day 0) 
Apheresis 
Visit  
(Day 0) 
Post 
Collection 
(Day 0 – 5) 
Infusion Day 
 (Study Day 5 
or BEST Day 0) 
Post-Infusion Days  
(Study Days 6-17 or 
BEST Days 1-12)a 
Obtain informed consent 
X 
 
 
 
 
Confirm eligibility 
X 
 
 
 
 
Collect demographics (date of birth, gender, race, ethnic origin), 
height, and weight 
X 
 
 
 
 
Record relevant medical history  
X 
 
 
 
 
Confirm participant is healthy  
 
X 
 
X 
 
Record any medications taken in the 7 days prior to apheresis 
procedure and through study completion 
 
X 
 
X 
X 
Confirm participant did not take any exclusionary medicationb 
 
X 
 
X 
X 
Fingerstick for Hgb or HCT  
 
X 
 
 
 
Conduct apheresis procedure per Trima Accel Operator’s Manual 
 
X 
 
 
 
Collect venous whole blood sample from diversion pouch and 
conduct CBC in duplicatec 
 
X 
 
 
 
Update Trima Accel machine with the averaged CBC results 
 
X 
 
 
 
Record serial numbers, lots, and expiry dates of equipment, 
disposables, and solutionsd 
 
X 
 
 
 
Record Trima End Run Summary Report detailse 
 
X 
 
 
 
Conduct CBC on platelet productf 
 
X 
 
 
 
Label productg  
 
 
X 
 
 
Store at 20°C  ̶  24°C with agitation away from normal blood 
inventory 
 
 
X 
 
 
Conduct bacterial testing on stored platelet producth 
 
 
X 
 
 
Conduct pregnancy test for women of child bearing potential (serum 
or urine) 
 
 
 
X 
 
Test stored platelet product pHi 
 
 
 
X 
 

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Screening  
Visit 
 (Day -5 – Day 0) 
Apheresis 
Visit  
(Day 0) 
Post 
Collection 
(Day 0 – 5) 
Infusion Day 
 (Study Day 5 
or BEST Day 0) 
Post-Infusion Days  
(Study Days 6-17 or 
BEST Days 1-12)a 
Collect whole blood sample and generate Control platelets according 
to BEST  
 
 
 
X 
 
Radiolabel Test and Control platelets according to BEST 
 
 
 
X 
 
Record vital signsj 
 
 
 
X 
 
Infuse radiolabeled autologous platelets (Test and Control) 
according to BEST 
 
 
 
X 
 
Collect 5-10 mL of whole blood into an EDTA tube for radiation 
counting 
 
 
 
Xk 
X 
Conduct radiation counting per BEST protocol 
 
 
 
X 
X 
Record AE, SAEs, or UADEs  
 
X 
 
X 
X 
Record medical interventions to treat AEs or SAEs 
 
X 
 
X 
X 
Review AEs/SAEs since previous visit, if applicable 
 
 
 
X 
X 
Record device deficiencies  
 
X 
 
X 
 
a Post-infusion visits will occur daily (except on weekends) from Study Day 6 through Study Day 12 (BEST Day 1-7). Additionally, 1 final visit will occur on 
Study Day 15, 16, or 17 (Best Day 10, 11, or 12). 
b Exclusionary medication includes aspirin or aspirin containing medications, NSAIDs, anti-platelet agents, or other drugs affecting platelet viability. 
c After venipuncture, a CBC will be done in duplicate for Hgb or HCT and platelet count. These averaged values will be used to update the Trima Accel 
machine.  
d Record Trima Accel machine serial number and lot number and expiration date of the disposable set, ACD-A, PAS adaptor, and InterSol used. 
e Record end run time, platelet volume, platelet yield, PAS volume added, and Trima flags that result in study discontinuation per Section 11.6.  
f Confirm platelet yield is ≥ 3.0 × 1011 and ≤ 5.1 × 1011 total platelets and platelet product concentration is 0.7 to 2.1 × 106/µL. 
g Label “For Investigational Use Only” and with USID number. 
h Bacterial testing conducted per site standard operating procedures with results confirmed on Study Day 5. 
i Confirm pH ≥ 6.2. 
j Vital signs taken prior to preinfusion sample collection and to include blood pressure, heart rate, and temperature. 
k Blood samples will be drawn pre-infusion and 2 hours ± 15 minutes after infusion. 
Abbreviations: AE = adverse event; BEST = Biomedical Excellence for Safer Transfusion Collaboration; CBC = complete blood count; 
EDTA = ethylenediaminetetraacetic acid; HCT = hematocrit; Hgb = hemoglobin; NSAID = non-steroidal anti inflammatory drug; PAS = platelet additive 
solution; SAE = serious adverse event; UADE = unanticipated adverse device effect; USID = unique subject identification. 

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11.1 
Screening Visit: Study Days -5 to 0 
Screening can be performed within 5 days before the apheresis procedure or combined with the 
Apheresis Visit.  
The following evaluations will be performed: 
1. Obtain informed consent prior to initiating any study specific procedures 
2. Confirm eligibility 
3. Collect demographics (date of birth, gender, race, ethnic origin), height, and weight  
4. Record relevant medical history  
11.2 
Apheresis Visit: Study Day 0 
The following procedures will be performed during the apheresis visit. 
11.2.1 
Prior to Apheresis 
1. Confirm participant is healthy  
2. Record any medications taken in the 7 days prior to the Apheresis Visit and during this 
visit  
3. Confirm the participant did not take any excludable medication (see Section 13) if 
screening visit was prior to apheresis visit 
4. Finger stick for Hgb or HCT testing 
11.2.2 
Apheresis Procedure 
Apheresis procedures will be run according to the instructions and precautions described in the 
commercially available Trima Accel Operator’s Manual. The procedure selection process 
(platelet yield, volume, and concentration) will be conducted per the site’s standard practice for a 
single platelet donation. 
The following procedures will be performed: 
1. Venipuncture 
2. Collect venous whole blood sample from the diversion pouch 
a. Conduct a complete blood count (CBC) in duplicate for Hgb or HCT and platelet 
count 
3. Update Trima Accel device with updated averaged platelet count and Hgb or HCT 
4. Perform apheresis procedure for a single hyperconcentrated platelet product 
5. Record the following: 

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a. Trima Accel machine serial number and lot number and expiration date of disposable 
set, ACD-A, PAS adaptor, and InterSol used 
b. Trima End Run Summary Report details 
i. End run time, platelet volume, platelet yield,  PAS volume added, and Trima flags 
that result in study discontinuation per Section 11.6 
c. AEs, SAEs, and UADEs starting from the time of venipuncture 
d. Medical interventions to treat AEs or SAEs 
e. Device deficiencies 
6. Conduct CBC on collected platelet product to confirm platelet yield and concentration 
conform to Trima Accel platelet storage bag specifications 
a. Record platelet yield and confirm platelets yield is ≥ 3.0 × 1011  and ≤ 5.1 × 1011  
b. Record platelet concentration and confirm it is within 0.7 to 2.1 × 106/µL 
11.3 
Post Collection Handling: Study Days 0 - 5  
Blood products collected in this study will be labeled ‘For Investigational Use Only’ and with the 
USID number and will be stored segregated from the site’s normal blood product inventory.  
The Test platelet units will be stored at 20ºC  ̶  24ºC with agitation for 5 days. Platelets will be 
tested for bacterial testing per the site’s SOP and all products that are negative will be used. Any 
product that is positive will be destroyed per the site’s SOPs and will not be radiolabeled or 
infused into the participant.  
11.4 
Infusion Day: Study Day 5 (BEST Day 0) 
Five (5) days after a study participant has donated a Test product, they will return for the 
donation of fresh Control platelets, reinfusion of Test and Control platelets, and post-infusion 
sampling. Study Day 5 corresponds to the Infusion Day/Day 0 in BEST. 
The following procedures will be conducted:  
1. Confirm participant is healthy and did not take any excludable medication 
2. Record any concomitant medications taken since previous visit and during this visit 
3. Conduct pregnancy test for women of childbearing potential (serum or urine) 
4. Test pH of the Test platelet product to confirm product meets FDA specifications 
(pH ≥ 6.2) 
5. Review AEs/SAEs since previous visit, if applicable 
6. Collect a whole blood sample per BEST procedures for the production of Control 
platelets  

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7. Radiolabel Test and Control platelets according to BEST 
When the combined injectate is ready for infusion, the following procedures will take place: 
1. Record vital signs (blood pressure, heart rate, temperature) prior to preinfusion sample 
collection  
2. Infuse radiolabeled autologous combined Test and Control platelets into participant’s 
vein per BEST procedure 
3. Collect a 5-10 mL sample into an EDTA tube for pre- and post-infusion testing using the 
opposite arm as for the infusion 
a. Prior to infusion 
b. 2 hours ± 15 minutes post-infusion 
4. Record AEs, SAEs, or UADEs 
5. Record medical interventions used to treat AEs or SAEs 
6. Record device deficiencies 
7. Conduct radiation counting per BEST protocol 
11.5 
Post-Infusion Days 
11.5.1 
Study Days 6-12 (BEST Days 1-7) 
The participant will return to the investigation site daily (except on weekends) between 
Study Day 6 and Study Day 12 (BEST Day 1 through Day 7). A total of 5 samples are required 
to be collected in this 7 day period in order for the participant’s data to be evaluable for primary 
endpoint analysis, per BEST.  
The participant procedures at each of these visits are as follows: 
1. Confirm participant did not take any exclusionary medication since previous visit (see 
Section 13) 
2. Record any concomitant medications taken since previous visit and during these visits  
3. Collect a 5-10 mL sample into an EDTA tube to measure radioactivity 
4. Conduct radiation counting per BEST protocol 
5. Record AEs, SAEs or UADEs experienced since previous visit and during visit 
6. Record medical interventions to treat AEs or SAEs 
11.5.2 
Study Day 16 ± 1 day (BEST Day 11 ± 1 day) 
The participant will return to the investigation site for 1 final sample on Study Day 15, 16, or 17 
which corresponds to BEST Day 10, 11, or 12. 

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The participant procedures at each of these visits are as follows: 
 
1. Confirm participant did not take any exclusionary medication since previous visit (see 
Section 13) 
2. Record any concomitant medications taken since previous visit and during this visit 
3. Collect a 5-10 mL sample into an EDTA tube to measure radioactivity 
4. Record AEs, SAEs, or UADEs experienced since previous visit and during visit 
5. Record medical interventions to treat AEs or SAEs 
11.6 
Study Procedure Discontinuation/Termination  
All participants are free to withdraw from the study at any time, for any reason, specified and 
unspecified, and without prejudice. The reason for the participant discontinuing study treatment 
or terminating from the study will be recorded on the Source Documents (SD) and eCRF. 
Reasons for study termination may include: 
1. Development of an AE that interferes with the participant’s continued participation 
2. Participant refuses further treatment and/or follow-up and withdraws consent 
3. Device deficiency or protocol deviation that ends the apheresis procedure early 
4. Inability to collect a complete platelet unit  
5. Procedure that produces a product quality Trima flag that results in the Test platelet 
product having insufficient yield, insufficient leukoreduction, or insufficient additive 
solution delivery 
6. Incomplete or incorrect post-collection processing due to equipment failure or 
malfunction (eg, under-delivery of PAS due to unrecoverable system failure or 
malfunctioning sterile barrier filter) 
7. Solution other than InterSol added to platelets prior to storage 
8. The collected platelet product falls outside of the Trima Accel platelet product storage 
boundaries: 
a. < 3.0 × 1011 or > 5.1 × 1011 total platelets 
b. Platelet product concentrations outside of 0.7 to 2.1 × 106/µL  
9. Product damaged during storage 
10. Positive pregnancy test 
11. Positive bacterial test 
12. pH of Test product < 6.2 
13. Investigator decision 

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14. Sponsor decision 
15. Participant is lost to follow-up or does not complete at least 5 of the post-infusion blood 
sampling for recovery and survival calculations 
16. Participant death 
17. Participant took exclusionary medication (see Section 13) 
11.7 
Stopping Rules 
There are no pre-specified stopping rules for this study. The Sponsor may stop the study for any 
reason. 
12 
LABORATORY TESTS 
12.1 
Clinical Laboratory Tests 
The clinical laboratory tests for the participant’s finger stick, the CBC (run in duplicate) for the 
Trima Accel update, and the pregnancy test on childbearing females prior to infusion of 
radiolabeled platelets will be analyzed locally at each study site. Copies of the current laboratory 
certifications and normal ranges will be provided to the Sponsor prior to start of the study and 
upon every renewal throughout the duration of the study. 
12.2 
Test Product Laboratory Test 
The Test platelet product will have a CBC conducted on Day 0 per Section 11.2.2, bacterial 
contamination testing conducted between Study Day 0 and Study Day 5 per site’s SOPs per 
Section 11.3, and pH testing conducted on Day 5 per Section 11.4.  
12.3 
Platelet Radiolabeling Procedures 
Radiolabeling of Test and Control platelets, the subsequent testing of participant blood samples 
for the primary endpoint analysis, and the calculations to determine the platelet recovery and 
survival will be conducted locally at each study site as outlined by the BEST collaborative in 
2006 9. The recovery and survival of platelets will be calculated at each site according to the 
COST software. 
All platelet products will be destroyed per the site’s SOPs after the final sample is taken. 
13 
CONCOMITANT MEDICATIONS 
Participants are prohibited from taking aspirin or aspirin containing medications for 7 days prior 
to the apheresis procedure, and NSAIDs, anti-platelet agents, or other drugs affecting platelet 

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viability for 3 days prior to the apheresis procedure.  Once enrolled in the study, participants are 
prohibited from taking these medications throughout their participation in the study.   
Concomitant medications taken from the 7 days before the apheresis visit until study exit will be 
recorded in the eCRFs. 
Medical interventions administered to treat AEs or SAEs will be recorded in the eCRFs. 
14 
ADVERSE EVENTS/EFFECTS 
14.1 
Anticipated Risks 
14.1.1 
Venipuncture Related 
The risks associated with venipuncture for blood sampling or intravenous (IV) access include 
apprehension, pain, discomfort, venospasm, fainting, bruising, infiltration at the venipuncture 
site, clotting in the IV tubing, and/or administrative errors. Occurrence rates of venipuncture AEs 
are summarized in Table 14-1. 
Table 14-1: 
Venipuncture Adverse Event Frequency 
Location 
Very Common 
≥ 1/10 
Common 
≥ 1/100 to  
< 1/10 
Uncommon 
≥ 1/1,000 to  
< 1/100 
Rare 
≥ 1/10,000 
to < 1/1,000 
Very rare 
< 1/10,000 
Not known 
Sporadic case 
reports 
General10-12 
Apprehension 
 
Presyncopea 
 
Faintb 
 
 
 
At puncture 
site11-14 
 
Hematoma 
 
Nerve 
irritation 
Arterial 
puncture 
 
Pain 
Infection 
Distant of 
puncture 
site11,12,14 
 
Discomfort 
 
 
Skin allergy 
Phlebitis 
Neuropathic 
pain 
 
DVT 
Abbreviations: DVT = deep vein thrombosis 
a Presyncope includes symptoms such as pallor, lightheadedness, dizziness, nausea, diaphoresis. 
b Faint defined as a brief loss of consciousness, usually less than 30 seconds. 
14.1.2 
Apheresis Complications in Healthy Donors  
Donor reactions are mostly transient self-limited events and in very rare exceptions a donor may 
experience long-term morbidity or sustain permanent impairment.11,14 Small hematomas, 
presyncopal episodes, and citrate reactions account for the majority of complications in 
automated collection procedures, and younger or first-time donors are more likely to experience 
complications.11-14 Although rare (< 5 out of 10,000 apheresis donations), almost 40% of 

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reactions requiring medical care outside the donation premises are venipuncture related, 
including large hematoma, and possible nerve irritation.14 
Apheresis donation is reasonably safe and the majority of complications are mild in nature. 
While definitions on severity differ in the literature, commonly used parameters to assess 
severity are the necessity for outside medical care, recovery time, and potential life-threatening 
consequences. Mild reactions consist of signs and symptoms with a normal recovery time (within 
14 min). Moderate reactions usually require medical care and/or have a prolonged recovery time 
(within 30 min), and severe reactions comprise life-threatening risks and/or recovery time goes 
beyond 30 min.11,13-15  Mild citrate reactions are very common with apheresis procedures, while 
vasovagal reactions are substantially lower compared to whole blood donation.12-14 Some donor 
reactions that have been previously reported for automated collection procedures are anxiety, 
chills, digit and/or facial paresthesia, fever, headache, hematoma, hyperventilation, hypotension, 
light-headedness, nausea and vomiting, fainting, unpleasant taste sensations, urticaria, and 
allergic reactions. Adverse reactions listed in Table 14-2 are general apheresis risks and are not 
specific to the Trima Accel system. 
Table 14-2: 
Apheresis Adverse Event Frequency 
Event type 
Very 
Common 
≥ 1/10 
Common 
≥ 1/100 to  
< 1/10 
Uncommon 
≥ 1/1,000 to  
< 1/100 
Rare 
≥ 1/10,000 to 
< 1/1,000 
Very rare 
< 1/10,000 
Not known 
Sporadic case 
reports 
Citrate 
Reactions13,14,1
6,17 
 
Paresthesia 
Nausea 
Vomiting 
Tetany 
Arrhythmia 
Cardiac arrest 
Lightheadedness 
Cramps 
Seizure 
Metallic taste 
Spasms 
Chills 
Vasovagal 
Reactionsa 12-
14,17 
 
 
Presyncopeb 
Vomiting 
Convulsion 
LOC with 
trauma injury  
 
Weakness 
Hypotension 
Seizure 
Syncope 
Bradycardia 
Other Notable 
Events12-14,17 
 
 
 
 
 
Respiratory 
distress 
Circulatory 
collapse 
Anaphylactic 
reaction 
Hemolysis 
Air emboli 
Death 
Abbreviations: LOC = loss of consciousness 
a Some events might be contributed to accidental (due to disposable/equipment failure causing additional blood loss) 
hypovolemia instead of a vasovagal reaction. 
b Presyncope includes symptoms such as pallor, lightheadedness, dizziness, nausea, diaphoresis. 

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14.1.3 
Apheresis Risks with the Trima Accel System 
Trima Accel disposable tubing sets are sterilized with ethylene oxide which may cause 
anaphylactic reactions. Though cases of allergic reactions to ethylene oxide are reported in 
literature, the Sponsor has no knowledge that any such event has occurred with the Trima Accel 
system to date. 
14.1.4 
Potential Risks of Infusion of Radiolabeled Platelets  
The amount of radiation exposure received by the participant is low and is not considered to be a 
health hazard.18 However, women who are pregnant or who are nursing will be excluded from 
the study, as the risks of radiation exposure to a fetus or infant are unknown. All enrolled women 
will have a pregnancy test performed before the re-infusion of the radiolabeled platelets as an 
added precaution. Any participant with a positive pregnancy test will be withdrawn from the 
study. 
14.2 
Risk Mitigation 
To minimize risks of participant injury, the following general procedures are to be followed: 
1. Ensuring that all Investigators are properly qualified and meet pre-specified criteria for 
Investigator selection and that they and their study teams successfully complete the 
following training: Site specific training, Human Participant Protection, and Clinical 
Investigation Plan (CIP) training to include device and procedure training.  
2. Ensuring that participants who are enrolled meet all eligibility criteria, including 
minimum Hgb or HCT and platelet limits for donation. The apheresis devices are 
programmed to allow collection of products only from participants who will meet 
projected HCT/Hgb and platelet standards at the completion of the collection. These 
limitations are for the safety of participants and apply to this CIP. 
3. If the Investigator deems appropriate, stopping the procedure if a moderate or severe AE 
occurs. The participant can also request that the procedure be stopped at any time. 
4. With the collection of protected health information (PHI) associated with this research 
study, there is a small risk of violation of privacy and loss of confidentiality. The 
apheresis collections will be documented on the study site’s SD. Case report forms will 
be uploaded to the electronic data capture (EDC) with only participant and product 
number as participant identifiers, to ensure confidentiality. 
5. Participants will be questioned concerning adverse experiences throughout the apheresis 
procedure. Participants will also be visually monitored for signs of distress during blood 

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donations. Suspected adverse reactions will be treated according to study sites’ SOPs and 
documented on the SD and eCRFs.  
14.3 
Adverse Event Definitions 
An AE is defined as any untoward medical occurrence in a clinical investigation participant, 
temporally associated with the use of a medical device, whether or not considered related to the 
medical device and/or procedure. Therefore, an AE can be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of the medical device and/or procedure. 
14.4 
Adverse Event Recording 
Adverse events that occur after the start of the apheresis procedure venipuncture until study 
completion will be recorded on the AE eCRF.  
14.5 
Adverse Event Reporting 
14.5.1 
Severity 
This study will utilize the Common Terminology Criteria for Adverse Events [CTCAE] Scale, 
Version 4.03 for AE grading.19 The CTCAE includes a grading (severity) scale for each AE term. 
Grades were developed using the following guidelines: 
Grade 0 – No AE or within normal limits. 
Grade 1 – Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
Grade 2 – Moderate; minimal, local or noninvasive intervention indicated. 
Grade 3 – Severe; medically significant but not immediately life threatening. 
Grade 4 – Life threatening. 
Grade 5 – Fatal. 
14.5.2 
Relationship 
The Investigator at each site will be asked to document his/her opinion of the relationship of the 
event to the device and/or procedure(s) as follows: 
Not Related: 
The event is clearly related to factors other than the study device and/or procedure(s), such as the 
participant’s clinical state. 

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Possibly Related:  
The event follows a reasonable temporal sequence from the time of study treatment 
administration/ procedure, and/or follows a known response pattern to study device/procedure(s) 
but could have been produced by other factors, such as the participant’s clinical state or other 
therapeutic interventions. 
Probably Related: 
The event follows a reasonable temporal sequence from the time of study device/procedure(s) 
and cannot be reasonable explained by other factors, such as the participant’s clinical state or 
therapeutic interventions. 
Definitely Related: 
The event follows a reasonable temporal sequence from the time of study device/procedure(s), 
and follows a known response pattern, and cannot be reasonably explained by other factors. In 
addition, the event occurs immediately following study procedure(s), and/or improves on 
stopping the study procedure, and/or reappears on resumption of study procedure(s). 
These criteria, in addition to good clinical judgment, should be used as a guide for determining 
the causal assessment. 
14.6 
Adverse Event Follow-up 
All AEs must be followed in accordance with the International Conference of Harmonization 
(ICH) Good Clinical Practice (GCP) guidelines, and other applicable regulatory requirements 
(eg, United States Code of Federal Regulations [CFR] 812). The expected AE of mild hematoma 
(bruise) and/or mild infiltration are not required to be followed to resolution.  
14.7 
Serious Adverse Events and Unanticipated Adverse Device Effect 
14.7.1 
Definition 
In the interest of participant care and to allow the Sponsor to fulfill all regulatory requirements, 
any SAE and/or UADE, regardless of causal relationship to study treatment/procedure(s), must 
be reported to the Sponsor within 24 hours of knowledge of the event. 
Serious AEs are defined (21 CFR 312.32 and ISO 14145:2011 Sec. 3.37) as those AEs which 
meet any of the following criteria: 
• Results in death.  
• Led to serious deterioration in the health of the participant, that either resulted in  
o A life-threatening illness or injury, or  

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o A permanent impairment of a body structure or a body function, or  
o Inpatient or prolonged hospitalization, or  
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalization for a pre-existing condition or a planned procedure, without 
serious deterioration in health, is not considered an SAE. 
Per 21 CFR 812.3 an UADE is defined as any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with a device, if that effect, problem or 
death was not previously identified in nature, severity, or degree of incidence in the CIP and/or 
Trima Accel Operator’s Manual, or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of participants. 
NOTE: Anticipated adverse device effects are effects, which by nature, incidence, severity or 
outcome have been identified in the CIP and/or Trima Accel Operator’s Manual. 
14.7.2 
SAE/UADE Reporting 
Any SAE/UADE that occurs after the start of the apheresis procedure venipuncture until study 
completion/termination must be reported. Follow-up (regardless of relationship to the study 
treatment/procedure[s]) must be reported and an AE/SAE/UADE Form must be submitted to the 
Sponsor within 24 hours of knowledge of the event to: 
Terumo BCT  
Email: ClinicalAffairs@TerumoBCT.com  
Fax: (303) 876-9146 
The Sponsor may request additional information from the Investigator to ensure the timely 
completion of accurate safety reports. 
Additionally the SAE/UADE must be entered on the AE page(s) of the eCRF. Follow-up 
SAE/UADE reports need to be submitted to the Sponsor as soon as additional information 
regarding the event becomes available. 
The Sponsor will be responsible for reporting SAE/UADEs to the regulatory authorities in 
accordance with applicable regulatory reporting guidelines. The Investigator is responsible for 
submitting SAE/UADEs to his/her Institutional Review Board (IRB) as required by local policy. 
Exclusions to SAE/UADE Reporting Requirements 
The following are not considered SAEs/UADEs: 

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• Planned hospitalization 
• Anticipated day-to-day fluctuations of pre-existing condition(s) present or detected at the 
start of the study that do not worsen 
14.8 
Clinical Investigation Plan Deviations 
A CIP deviation is defined as any event where the Investigator or site personnel deviate from the 
study CIP or study procedures for any reason. 
The Sponsors is responsible for reporting all deviations into the EDC. Clinical Investigation Plan 
deviations that may affect the scientific soundness of the study or affect the rights, safety, or 
welfare of study participants, must be reported to the Sponsor and the IRB as per the IRB’s 
standard reporting procedure. 
14.9 
Medical Monitoring 
It is the responsibility of the Investigator to oversee the safety of the study at his/her site. A Data 
Safety Monitoring Board will not be involved in this study because it involves healthy 
participants undergoing a commonly practiced research evaluation procedure and no 
investigational product will be transfused. 
The Sponsor will monitor the safety of the study participants from the venipuncture for the 
apheresis procedure and until conclusion of their participation in the study.  
15 
STUDY DEVICE 
15.1 
Device Deficiencies 
All device deficiencies involving any device component must be reported within 24 hours upon 
knowledge to the Sponsor utilizing the Device Deficiency Report Form. Every attempt should be 
made by the site to save or collect the defective device, and if appropriate, the packaging, for 
return to the Sponsor. A qualified company representative will investigate and determine root 
cause and corrective actions as applicable, and directives will be provided to the site if 
warranted. 
15.2 
Device Accountability 
15.2.1 
Receipt of Study Device 
The contents should be examined upon receipt to ensure packaging and labeling is intact and the 
devices have not been damaged. Any damage should be immediately reported to the Sponsor. 

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15.2.2 
Storage 
The Trima Accel device, the InterSol, and the disposables should be stored in a dry place at room 
temperature. Proper care should be taken to ensure that the study inventory will not be damaged. 
15.2.3 
Accountability 
The Trima Accel device, disposables, InterSol, and software will be provided by the Sponsor for 
use in this study. The Trima Accel disposables, software, and InterSol are FDA cleared and 
marketed in the United States; however platelets collected on the Trima Accel system and stored 
in InterSol is not, therefore the site must take appropriate measures to ensure it is properly stored 
away from approved inventory.  
16 
STATISTICAL PLAN 
16.1 
Sample Size 
Assuming an approximate 40% screen fail/early termination rate, up to 40 healthy adult 
participants will be enrolled in this study to ensure 24 evaluable data points across 
2 investigational sites in the United States.  
Donors will be selected from the community donor and/or research pool and will be 
representative of the healthy adult volunteer population. Participants will be recruited in a 
non-coercive manner and recruitment will be irrespective of ethnicity or gender. 
16.2 
Outcome Measures 
This study will determine the recovery and survival of hyperconcentrated platelets collected on 
the Trima Accel system and stored for 5 days in 65% InterSol/35% plasma. The recovery and 
survival of Test platelets will be compared to fresh Control platelets. 
16.2.1 
Primary Endpoint 
The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority 
by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: 
Null Hypothesis 
 
H0:  µd ≤ 0 
where µd=µT-0.66*µC 
Alternate Hypothesis  
H1:  µd > 0 
Let ∆Xi = (XTi-0.66*XCi) be a difference if recovery for patient i. The sample mean and standard 
deviations of these observed differences will be used to construct the lower limit of a 1-sided 
97.5% confidence interval for µd assuming a t-distribution with n-1 degrees of freedom. If the 
lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in 

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favor of the alternative hypothesis suggesting the Test product meets the FDA acceptance criteria 
for platelet recovery. 
The acceptance criterion for the survival (hours) of platelets is the demonstration of 
non-inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses: 
Null Hypothesis 
 
H0:  µd ≤ 0 
where µd=µT-0.58*µC 
Alternate Hypothesis  
H1:  µd > 0 
Let ∆Xi = (XTi-0.58*XCi) be a difference in survival for patient i. The sample mean and standard 
deviations of these observed differences will be used to construct the lower limit of a 1-sided 
97.5% confidence interval for µd assuming a t-distribution with n-1 degrees of freedom. If the 
lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in 
favor of the alternative hypothesis suggesting the Test product meets the FDA acceptance criteria 
for platelet survival. 
16.2.2 
Safety Measures 
Adverse events will be summarized by the medical dictionary for regulatory activities (MedDRA 
Version 18.1 or later) and verbatim term. Tables will describe the frequency and percentage of all 
AEs, SAEs, and UADEs reported by participants in the safety population. Presentations will 
summarize AEs by maximum reported severity and relationship to device and procedure. 
Adverse events leading to study or procedure discontinuation will also be tabulated.  
16.3 
Analysis Population 
The safety population will include all participants enrolled in this trial who undergo any study 
related apheresis procedure.  
The Full Analysis Set (FAS) will consist of all completed procedures/products where the 
corresponding Test and Control values for the primary endpoint are valid. If any of the criteria 
outlined in Section 16.4 are met, the product will not be included in the FAS. The FAS will be 
used to examine the primary endpoints. 
16.4 
CIP Analysis Exclusions 
Data points may be excluded from analysis in the following situations: 
1. Primary endpoint laboratory samples are lost or not available 
2. Failure of the site to follow post-collection handling procedures for endpoint assays  

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17 
STUDY MANAGEMENT 
17.1 
Investigator Responsibilities 
17.1.1 
Investigator Agreement 
Each Investigator will provide the Sponsor a copy of his/her current curriculum vitae and a 
signed Investigator Agreement, prior to initiation of the study.  
17.1.2 
Institutional Review Board 
The IRB or other committee functioning in a similar capacity will review and approve the CIP 
and any CIP amendments, initial and revised informed consent (IC) documents, and recruitment 
materials, if applicable. After approval by the IRB, documentation of approval and the approved 
IC document will be sent to the Sponsor before any participant is enrolled into this study. 
17.1.3 
Informed Consent 
The Investigator is responsible for preparing the written IC document for this study. The Sponsor 
will provide the Investigator an IC template. The Investigator may rearrange or reword the 
contents of the template, or may add other elements or language, provided the meaning and 
content are not changed or deleted. 
Prior to participant participation in this study, the Investigator must obtain written IRB approval 
for the CIP and the ICF. The approved consent form will clearly reflect the IRB approval date.  
Once the participant’s initial eligibility has been determined, the Investigator or person 
designated by the Investigator, who has been trained on the CIP, will explain the nature and 
scope of the study, potential risks and benefits of participation, answer questions for the 
participant and ask the participant to participate in the study. The study will be explained to the 
study participant in lay terms, in their native language in a quiet, non-disruptive setting. Potential 
participants will be given as much time and privacy as necessary to review the informed consent 
prior to agreeing to participate in the study. Additionally, if the participant desires, they can take 
a copy of the consent with them so that they can discuss potential participation with others 
outside the study team. If the participant agrees to participate, the participant has read the ICF, 
and has had all of their questions answered, then the ICF must be signed and personally dated by 
the participant and the person completing the consent process. A copy of the signed and dated 
ICF will be provided to the study participant.  
All participants are free to withdraw from participation in this study at any time, for any 
reason(s), specified or unspecified, and without prejudice. The reason(s) for the participant 
discontinuing or terminating from the study must be recorded on the eCRF. 

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17.1.4 
Study Files and Record Retention 
Investigational sites will maintain all records pertaining to this study for a minimum of 2 years 
following pre-market approval or 2 years after the study is discontinued. The sponsor will notify 
investigational sites of the discontinuation. Prior to discarding any study-related records, all 
clinical sites must contact the sponsor for direction.  
17.1.5 
Regulatory Compliance 
Sites are responsible for meeting all applicable FDA regulations (eg, 21 CFR 600-680 and 
21 CFR 800) and AABB standards. Sites will be responsible for staying current on new standards 
and meeting any new regulations which may be implemented during the course of this study. 
17.2 
Sponsor Responsibilities 
17.2.1 
Amendments to the CIP 
Any amendment to the CIP, as deemed appropriate by the Sponsor, will be implemented as the 
study progresses. Amendments will be submitted to the FDA and IRB for written approval, 
before implementation.  
17.2.2 
General Responsibilities 
As per International Organization for Standardization (ISO) 14145 Section 8 and 21 CFR 812, 
Terumo BCT is responsible for selecting qualified Investigators and providing them with the 
information they need to conduct the investigation properly, ensuring quality study conduct and 
proper monitoring of the investigation, ensuring required approvals are obtained and that 
significant new information about an investigation is promptly reported to reviewing IRB and 
government authorities as well as annual reports as required.  
17.3 
Joint Investigator-Sponsor Responsibilities 
17.3.1 
Training 
The Sponsor will train applicable study team members as to the device, CIP, and study 
procedures and will provide updated information as it becomes available during the course of the 
study, if applicable. The Investigator is responsible for ensuring that additional site personnel that 
were not trained by the Sponsor receive applicable documents and training.  
17.4 
Collecting and Recording Data 
The Investigators will maintain complete, accurate, legible, and easily retrievable data, and will 
allow personnel authorized by the Sponsor access to all study data at any time. Such data shall 
also be secured in order to prevent loss of data. 

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All required data for this study will be recorded from the source documentation onto 
standardized eCRFs.  
17.4.1 
Source Documents 
Source data is all information, original records of clinical observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of that trial. Source data are 
contained in source documents. Examples of these original documents and data records include 
Blood Center records, evaluation checklists, and laboratory results. 
17.4.2 
Case Report Forms 
The study eCRF via EDC is the primary data collection instrument for the study. All data must be 
recorded in English. Any missing data must be explained.  
Completed eCRFs will be reviewed and signed by the Investigator. The clinical research 
associate will verify the EDC data with the participant’s source data, evaluate the data for 
accuracy, consistency, and completeness, and will ensure that all forms with missing data and/or 
errors are ultimately addressed. Accurate and complete eCRFs for a participant must be 
completed in a timely manner. 
17.5 
CIP Compliance 
The Investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this CIP.  
17.6 
Termination of the Study 
For reasonable cause, either the Investigator or the Sponsor may terminate the Investigator’s 
participation in this study, provided a written notice is submitted within the time period provided 
for in the Clinical Trial Agreement (CTA). In addition, the Sponsor may terminate the study at 
any time upon immediate notice for any reason, including but not limited to, the Sponsor’s belief 
that termination is necessary for the safety of participants or failure to meet the primary 
endpoints. 
17.7 
Publication Policy 
The Sponsor recognizes the importance of communication of medical study data, and encourages 
the publication of such data in reputable scientific journals and the presentation of such data at 
scientific seminars and conferences. Any proposed publication or presentation of the data 
generated from the study must be provided to the Sponsor for timely review in accordance with 
the terms of the CTA between the Investigator, the Institution, and the Sponsor. The Sponsor 
shall not, in its scientific publications or promotional material, quote from publications by 

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Investigators without full acknowledgment of the source. As this will be a multi-site study, all 
Investigators agree not to publish individual site data. All study data will be published as 1 or 
more manuscripts based on the accumulated data from all study sites.  

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18 
REFERENCES 
1. 
Alhumaidan H, Sweeney J. Current status of additive solutions for platelets. J Clin 
Apher. 2012;27(2):93-98. 
2. 
Holme S, Heaton WA, Whitley P. Platelet storage lesions in second-generation 
containers: correlation with in vivo behavior with storage up to 14 days. Vox Sang. 
1990;59(1):12-18. 
3. 
Slichter SJ, Corson J, Jones MK, et al. Exploratory studies of extended storage of 
apheresis platelets in a platelet additive solution (PAS). Blood. 2014;123(2):271-280. 
4. 
Fenwal. InterSol Solution: Platelet Additive Solution 3. 2009. 
5. 
CBER. Guidance for Industry and FDA Review Staff: Collection of Platelets by 
Automated Methods. 2007. 
6. 
TerumoBCT. CTS-5051: In Vitro Study of Platelets Collected on Trima Accel System 
and Stored in InterSol Solution. 2016. 
7. 
Dumont LJ, Cancelas JA, Graminske S, et al. In vitro and in vivo quality of leukoreduced 
apheresis platelets stored in a new platelet additive solution. Transfusion. 
2013;53(5):972-980. 
8. 
United States Food and Drug Administration; Blood Products Advisory Committee. New 
Standard for Platelet Evaluation. 2004. 
9. 
Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Platelet 
Radiolabeling Procedure. Transfusion 2006;46(Suppl 3):59S-66S. 
10. 
Deacon B, Abramowitz J. Fear of needles and vasovagal reactions among phlebotomy 
patients. J Anxiety Disord. 2006;20(7):946-960. 
11. 
Sorensen BS, Johnsen SP, Jorgensen J. Complications related to blood donation: a 
population-based study. Vox Sang. 2008;94(2):132-137. 
12. 
Gavillet M, Tissot JD, Canellini G. Blood donation associated risks: data from a Swiss 
regional haemovigilance program. Transfus Med. 2013;23(4):269-271. 
13. 
McLeod BC, Price TH, Owen H, et al. Frequency of immediate adverse effects 
associated with apheresis donation. Transfusion. 1998;38(10):938-943. 
14. 
Eder AF, Dy BA, Kennedy JM, et al. The American Red Cross donor hemovigilance 
program: complications of blood donation reported in 2006. Transfusion. 
2008;48(9):1809-1819. 
15. 
Wiltbank TB, Giordano GF. The safety profile of automated collections: an analysis of 
more than 1 million collections. Transfusion. 2007;47(6):1002-1005. 
16. 
Makar YF, Butler MO, Cockersole GM, Gabra G, Serevitch JM. National audit of citrate 
toxicity in plateletpheresis donors. Transfus Med. 2002;12(3):187-191. 
17. 
Crocco I, Franchini M, Garozzo G, et al. Adverse reactions in blood and apheresis 
donors: experience from two Italian transfusion centres. Blood Transfus. 2009;7(1):35-
38. 
18. 
HL Taylor PW, A Heaton. A historical perspective on platelet radiolabeling techniques. 
Transfusion. 2006;46:53S-58S. 
19. 
Program. NCIUCTE. Common Terminology Criteria for Adverse Events:(CTCAE). 
Cancer Therapy Evaluation Program. 2003. 
 

InterSol In Vivo Platelet Quality Study 
Terumo BCT, Inc. 
Clinical Investigation Plan: CTS-5066 
Version 2.0: 10 JUL 2017 
Confidential  
Page 45 of 46 
Appendix 1 
 Investigator Signature 
Study Title:  
An In Vivo Recovery and Survival Study of Platelets Collected on 
the Trima Accel System and Stored in InterSol Solution  
 
Study Number 
 
Version/Date: 
CTS-5066 
 
2.0 / 10 JUL 2017 
I have read the Clinical Investigation Plan (CIP), including all appendices, and I agree that it 
contains all necessary details for me and my staff to conduct this study as described. I will 
conduct this study in compliance with the CIP, GCP, and all applicable regulations. I will make a 
reasonable effort to complete the study within the time designated. 
I will provide all study personnel under my supervision with copies of the CIP and access to all 
information provided by Terumo BCT. I will discuss this material with them to ensure that they 
are fully informed about the study. 
 
 
 
 
Principal Investigator Name (Printed) 
 
Signature 
 
 
 
 
Date 
 
 

InterSol In Vivo Platelet Quality Study 
Terumo BCT, Inc. 
Clinical Investigation Plan: CTS-5066 
Version 2.0: 10 JUL 2017 
Confidential  
Page 46 of 46 
Appendix 2 
BEST Collaborative Platelet Radiolabeling Procedure