Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in 100% Plasma
Phase: NA
Conditions: Healthy Volunteers
Sponsor: Terumo BCT

Trima Accel® system 
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Clinical Investigation Plan: CTS-5060 
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CLINICAL INVESTIGATION PLAN 
Study Title: 
Evaluation of the Performance of Trima Accel® Version 7.0 
Software Enhancements for the Collection of Platelets Stored in 
100% Plasma 
Study Number: 
CTS-5060 
Study Device: 
Trima Accel® system 
Manufacturer: 
Terumo BCT, Inc. 
10811 West Collins Avenue 
Lakewood, CO 80215 USA 
Phone: (303) 231-4832 
Sponsor: 
Terumo BCT, Inc. 
10811 West Collins Avenue 
Lakewood, CO 80215 USA 
Phone: (303) 231-4832 
Sponsor Contact: 
Raymond P. Goodrich, PhD 
Phone: (303) 231-4357 
Email: Ray.Goodrich@terumobct.com  
This study will be conducted according to this protocol, 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 14155:2011(E), and other regulatory requirements of the 
regions where the study is conducted. All essential documents will be archived. 
 
Version/Date: 
3.0/19 FEB 2016 
 
Confidentiality Statement 
The information contained in this document, particularly unpublished data, is the property or 
under control of Terumo BCT, Inc., 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 protocol. You will not 
disclose any of the information to others without written authorization from Terumo BCT 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. 
 

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Clinical Investigation Plan: CTS-5060 
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CLINICAL INVESTIGATION PLAN APPROVAL 
Name: 
Raymond P. Goodrich, PhD 
 
 
Title: 
VP Science & Clinical Affairs, Chief Science Officer-BBT 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
 
Name: 
Beth Crump, RN, BSN 
 
 
Title: 
Director, Global Clinical Affairs 
 
 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
 
Name: 
Jerome R. Bill, MD 
 
 
Title: 
Medical Monitor 
 
 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
 
Name: 
Marty Huntington, MS 
 
 
Title: 
Clinical Affairs Manager 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
 
Name: 
Matt Hudson, MS 
 
 
Title: 
Senior Director, Biostatistics, Prosoft Software, Inc. 
 
 
 
 
Signature: 
 
Date: 
 
 
 
 
 
Name: 
Title 
 
 
Signature 
Pamela Lopert, PhD 
Clinical Research Lead 
 
 
 
 
Date: 
 
 
 
 
 

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AMENDMENT 2 SUMMARY OF CHANGES 
Study Title: 
Evaluation of the Performance of Trima Accel® Version 7.0 Software 
Enhancements for the Collection of Platelets Stored in 100% Plasma 
CIP #: 
CTS-5060 
CIP Version / Date: 
Version 3.0/19 FEB 2016 
Replaces CIP Version / Date: 
Version 2.0/19 NOV 2015 
Rationale: 
This amendment was made to clarify the subject exclusion criterion to make 
clear that only 1 evaluable platelet product will be included in the final analysis 
per unique individual, added a section to ensure sites are aware of the need to 
record concomitant medications in the event of an adverse event (AE), updated 
the protocol analysis exclusion criteria for better clarity regarding which 
products will be excluded in the final analysis, and updated when to start 
documenting adverse events and what subjects will be included in the safety 
population for consistency throughout the document. The amendment includes 
the following significant changes: 
1. The exclusion criterion has been revised. The previous exclusion criterion 
prevented a subject from being reenrolled if they were a screen failure or 
had an incomplete procedure, which was unnecessarily restrictive. The 
intent is to ensure all products in the Full Analysis Set (FAS) are collected 
from unique individuals. The new language therefore specifically excludes 
subjects who have already donated an evaluable platelet product in this 
study.  
2. The Study Procedures section (Section 10) has been updated to match the 
data that will be collected on the electronic case report forms (eCRFs). The 
dilution factor, donor identification number, and blood pressure cuff used 
are data that are needed for the study and were unintentionally omitted in 
the previous version. This update will ensure sites are aware of the need to 
collect these data. 
3. Language has been added (Section 12) to provide clarity regarding 
concomitant medications. Specifically, medications administered to treat 
AEs will be recorded on the site source documents and eCRFs.    
4. The protocol analysis exclusions (Section 15.4) were updated to provide 
clarity regarding the types of procedures and products to be excluded from 
the FAS. These clarifications include the addition of 2 exclusion criteria 
and the correction of typographical errors. Specifically, new exclusion 
criteria were added for procedural or donor issues that would result in an 
incomplete or incorrect product collection. The correction of the 
typographical errors ensures sites are aware that products will be excluded 
due to incorrect collection and incorrect post collection handling of the 
products.  
5. The adverse event recording and definition of the safety population were 
updated. These changes were made to make sure sites record any AE(s) that 
occur after a donor signs the informed consent form and updated the 
definition of the safety population to ensure it represents the appropriate 
study population.  
Additionally, administrative changes, section numbering, typographical error 
corrections, 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 and Section 9.3 
Exclusion Criteria 
1. Has been previously enrolled in 
this study (CTS-5060). 
1. Has previously donated an evaluable 
platelet product in this study (CTS-5060) 

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Section 9.4 Enrollment 
After informed consent has been 
obtained, subjects will receive a 
subject number assigned by the 
electronic data capture (EDC) 
system. The subject number will 
be recorded on the electronic Case 
Report Form (eCRF).   
Subjects that fail screening criteria 
on information or laboratory 
values that are anticipated to 
change, may be rescreened. 
Subjects that have incomplete 
procedures may rescreen if they 
meet all inclusion criteria when 
they return. Subjects that are 
rescreened will be assigned a new 
subject number. 
After informed consent has been obtained, 
subjects will receive a unique study 
identification number (USID). The 
USID number will use the following 
convention: 60XX-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).   
Subjects that fail screening criteria on 
information or laboratory values that are 
anticipated to change, may be rescreened. 
Subjects that have incomplete procedures 
or donated a product that meets any of 
the protocol analysis exclusions 
(Section 15.4) may rescreen if they meet 
all inclusion criteria when they return. 
Subjects that are rescreened will be 
assigned a new USID number.  
Section 10.1 Screening 
(Days -30 to 1) 
1. Informed consent will be 
obtained prior to initiating any 
study specific procedures. 
2. Eligibility will be confirmed. 
3. Demographics (age, gender, 
ethnic origin), height, and weight 
will be collected. 
4. Venipuncture will be conducted 
for hemoglobin or hematocrit and 
platelet count on subjects who are 
new to the Site and who do not 
have recent and/or historical 
hemoglobin and/or platelet count 
measurements. 
1. Informed consent will be obtained prior 
to initiating any study specific procedures. 
2. Eligibility will be confirmed. 
3. Demographics (age, gender, ethnic 
origin), height, weight, and donor 
identification number will be collected. 
4. Venipuncture will be conducted for 
hemoglobin or hematocrit and platelet 
count on subjects who are new to the Site 
and who do not have recent and/or 
historical hemoglobin and/or platelet count 
measurements. 
5. Record any AEs and SAEs.  

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Section 10.2.2 Apheresis 
Procedure 
1. Venipuncture.  
2. Collect venous whole blood 
sample. 
a. Complete blood count 
(hemoglobin count, hematocrit 
percentage and platelet count). 
3. Update Trima Accel device with 
updated platelet count. 
4. Perform apheresis procedure. 
5. Record the following: 
a.Trima procedure details . 
b. AEs, SAEs and UADEs. 
c. Medical interventions to treat 
AEs, if applicable. 
d. Device deficiencies. 
1. Venipuncture.  
2. Collect venous whole blood sample. 
a. Complete blood count (hemoglobin 
or hematocrit and platelet count). 
3. Update Trima Accel device with 
updated platelet count and hemoglobin or 
hematocrit. 
4. Perform apheresis procedure. 
5. Record the following: 
a. Type of cuff used. 
b. Trima procedure details. 
c. AEs, SAEs and UADEs. 
d. Medical interventions to treat AEs, if 
applicable. 
e. Device deficiencies. 
Section 10.2.3 Data from 
Collected Platelet and Plasma 
Products 
1. Platelet Product 
a. Residual WBC count. 
b. Complete blood count test 
(platelet count). 
c. Product weight. 
1. Platelet Product 
a. Dilution factor  
b. Residual WBC count. 
c. Complete blood count test (platelet 
count). 
d. Product weight. 
Section 12 Concomitant 
Medications 
Has been added 
Medications administered to treat AEs 
will be recorded on the site source 
documents and eCRFs. 
Section 13.4 Adverse Event 
Recording 
Adverse events that occur during 
screening venipuncture to 
discharge and from venipuncture 
for apheresis procedure until 
discharge will be recorded on the 
AE eCRF. 
Adverse events that occur after signing 
the informed consent form (ICF) will be 
recorded on the AE eCRF. 
Section 13.7.2 SAE/UADE 
Reporting 
Any AE/SAE/UADE that occurs 
from the apheresis visit until study 
completion/termination must be 
reported. 
Any AE/SAE/UADE that occurs after 
signing the ICF until study 
completion/termination must be reported. 
Section 15.3 Analysis 
Populations 
The safety population will include 
all donors enrolled in this trial who 
undergo any study related invasive 
procedure. 
The safety population will include of all 
subjects enrolled in this trial for whom at 
least 1 apheresis procedure is initiated. 
Section 15.4 Protocol 
Analysis Exclusions 
1. Inability to collect a complete 
unit due to: 
a. Subject issues (inadequate 
access, reaction, needle abort). 
1. Inability to collect a complete unit due 
to: 
a. Subject issues (inadequate access, 
reaction, needle abort, procedure 
disqualification upon Trima Accel 
device update of subject platelet count 
and hemoglobin or hematocrit). 

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Section 15.4 Protocol 
Analysis Exclusions 
4. Incomplete or incorrect post-
collection processing due to: 
a. Equipment failure or 
malfunction. 
b. Failure to follow post-
collection handling procedure 
outlined in Section 4, the Trima 
Operator’s Manual, and 
supplement(s). 
c. Donor and procedure samples 
are not taken as specified in 
protocol. 
d. Solution other than InterSol 
added to platelets prior to 
storage. 
e. Laboratory samples are lost or 
results of critical assays not 
available. 
4. Incomplete or incorrect collection 
procedure or post-collection processing 
due to: 
a. Equipment failure or malfunction. 
b. Subject issues (inadequate access, 
reaction, needle abort). 
c. Unanticipated centrifuge stop 
during collection procedure. 
d. Failure to follow collection or post-
collection handling procedure outlined in 
the Trima Operator’s Manual, and 
supplement(s). 
e. Subject and procedure samples are 
not taken as specified in protocol. 
f. Solution other than InterSol added to 
platelets prior to storage. 
g. Results of endpoint assays are not 
available. 
 

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SYNOPSIS 
Sponsor: 
Terumo BCT, Inc. 
Study Title: 
Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements 
for the Collection of Platelets Stored in 100% Plasma 
Study Number: 
CTS-5060 
Target Population: 
Healthy Adults 
Device Description: 
The 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 Anticoagulant Citrate Dextrose, Solution 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 bags, platelet bags, 
a seal safe system, and barcode scanner kit. 
The Trima Accel system received United States Food and Drug Administration (FDA) 
510(k) clearance for platelet collections stored in plasma on 13 October 1998 
(BK970023). 
Intended Use: 
The Trima Accel system is an automated blood cell separator intended for use in 
collecting blood components for later transfusion into patients. 
Study Centers Planned: 
At least 2 and up to 8 Blood Centers in the United States 
Objective: 
To verify that platelets collected on the Trima Accel system with Version 7.0 software 
enhancements and stored in 100% plasma meet the FDA requirements for 
leukoreduction (< 5.0 × 106 residual white blood cells [WBC] per transfusable unit). 
Rationale: 
The study is designed to evaluate changes to the Trima Accel software to ensure the 
modified software meets the FDA acceptance criteria for leukoreduction and platelet 
yield. The operating range for the system flow rates, anticoagulant ratios, storage 
conditions, and centrifugal forces are the same as the currently cleared Trima Accel 
system. There are no changes to the environment or storage conditions for platelets, 
therefore, no in vitro or in vivo platelet quality data will be collected.  
Outcome Measures: 
Primary Endpoint: 
The proportion of platelet units with an acceptable residual WBC level. Acceptable 
residual WBC counts are: singles = residual WBC level < 5.0 × 106; doubles = residual 
WBC level < 8.0 × 106 or < 5.0 × 106 for each transfusable unit; and triples = residual 
WBC level < 12.0 × 106 or < 5.0 × 106 for each transfusable unit. 
Secondary Endpoint: 
The proportion of platelet units with an acceptable platelet yield. Acceptable platelet 
yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 1011 for 
singles, platelet yield ≥ 6.2 × 1011 for doubles, and platelet yield ≥ 9.3 × 1011 for 
triples. 
Safety Measures: 
Safety will be monitored through collection of adverse events (AEs), serious adverse 
events (SAEs), and unanticipated adverse device effects (UADEs). 

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Inclusion Criteria: 
1. Age 18 years or older. 
2. Meets the inclusion criteria defined by the Blood Center for an apheresis platelet 
with plasma collection on the Trima Accel system. These criteria are based on FDA 
guidance and the American Association of Blood Banks (AABB) standards. Note: 
subjects who are deferred from volunteer community donations because of travel 
restrictions, piercings, or tattoos may participate in the study, as products are not 
transfused. 
3. Has given written informed consent. 
Exclusion Criteria: 
1. Has previously donated an evaluable platelet product in this study (CTS-5060). 
Number of Subjects 
Planned: 
Up to 350 healthy adult subjects will be enrolled in this study to complete 93 single, 
93 double and 93 triple collections. 
Study Design: 
This is a prospective, open-label, multi-center controlled study to evaluate the 
leukoreduction of platelets stored in 100% plasma collected on the Trima Accel system 
Version 7.0 software enhancement. Up to 350 healthy adult subjects will be enrolled in 
this study to ensure 93 single, 93 double and 93 triple platelet product evaluable data 
points. Evaluable is defined as a completed platelet product that does not meet any of 
the protocol analysis exclusion criteria. 
Plateletpheresis will be per site standard practice and per applicable FDA guidelines 
such as the FDA Collection of Platelets by Automated Methods, December 2007 
Guidance for Industry and Pre-storage Leukocyte Reduction of Whole Blood and 
Blood Components Intended for Transfusion, September 2012. 
Study Duration: 
Study participation will be up to 30 days and will consist of 1 to 2 visits. Screening 
may be done within 30 days of the apheresis procedure or combined as a single visit, 
which includes screening and the apheresis procedure all in 1 day. 
The entire study should be completed in approximately 16 months. 
Statistical 
Methodology: 
Counts and percentages of success rates and the lower one-sided 95% exact binomial 
confidence intervals will be calculated separately for success rates of single, double, 
and triple platelet products. If 0 or 1 failure is observed, then the confidence interval 
will suggest that the true success rate is at least 95% with 95% confidence for the given 
platelet product. This approach will be applied independently to single, double, and 
triple platelet products. 
Also applied independently to single, double, and triple platelet products, the lower 
one-sided 95% exact binomial confidence intervals will be calculated for the 
proportion of platelet units with an acceptable platelet yield. If 16 or fewer failures are 
observed, then the confidence interval will suggest that the true success rate is at least 
75% with 95% confidence for the given platelet product. 
 

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TABLE OF CONTENTS 
1 
INTRODUCTION......................................................................................................14 
1.1 
Background ......................................................................................................14 
2 
DEVICE DESCRIPTION .........................................................................................14 
2.1 
Version 7.0 Software .......................................................................................15 
2.2 
Arm Cuff ..........................................................................................................16 
2.3 
Disposable Sets ................................................................................................17 
3 
INTENDED USE STATEMENT .............................................................................17 
4 
NONCLINICAL STUDIES.......................................................................................17 
5 
CLINICAL TRIAL EXPERIENCE .........................................................................17 
5.1 
Standard Platelet Leukoreduction Improvements ............................................17 
5.2 
Platelet Yield and Procedure Time Improvements ..........................................18 
6 
RATIONALE FOR THE CURRENT STUDY .......................................................18 
7 
ENDPOINTS ..............................................................................................................19 
7.1 
Primary Endpoint .............................................................................................19 
7.2 
Secondary Endpoint .........................................................................................19 
7.3 
Safety Measures ...............................................................................................20 
8 
INVESTIGATIONAL PLAN ...................................................................................20 
8.1 
Study Design ....................................................................................................20 
8.2 
Study Duration .................................................................................................20 
9 
STUDY POPULATION ............................................................................................21 
9.1 
Number of Subjects and Selection ...................................................................21 
9.2 
Inclusion Criteria .............................................................................................21 
9.3 
Exclusion Criteria ............................................................................................21 
9.4 
Enrollment........................................................................................................21 
10 
STUDY PROCEDURES ...........................................................................................22 
10.1 
Screening (Days -30 to 1) ................................................................................22 
10.2 
Day of Apheresis (Day 1) ................................................................................22 
10.2.1 
Prior to Apheresis .............................................................................22 
10.2.2 
Apheresis Procedure .........................................................................22 
10.2.3 
Data from Collected Platelet and Plasma Products ...........................23 
10.3 
Study Procedure Discontinuation/Termination................................................23 

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11 
LABORATORY TESTS ...........................................................................................24 
12 
CONCOMITANT MEDICATIONS ........................................................................24 
13 
ADVERSE EVENTS/EFFECTS ..............................................................................24 
13.1 
Anticipated Risks .............................................................................................24 
13.1.1 
Potential Apheresis Related Risks ....................................................24 
13.1.2 
Venipuncture Related........................................................................24 
13.1.3 
Apheresis Complications in Healthy Donors ....................................25 
13.1.4 
Apheresis Risks with the Trima Accel System .................................26 
13.2 
Risk Mitigation ................................................................................................26 
13.3 
Adverse Event Definitions ...............................................................................27 
13.4 
Adverse Event Recording ................................................................................27 
13.5 
Adverse Event Reporting .................................................................................27 
13.5.1 
Severity .............................................................................................27 
13.5.2 
Relationship ......................................................................................28 
13.6 
Adverse Event Follow-up ................................................................................28 
13.7 
Serious Adverse Events and Unanticipated Adverse Device Effect ................29 
13.7.1 
Definition ..........................................................................................29 
13.7.2 
SAE/UADE Reporting ......................................................................30 
13.8 
Clinical Investigation Plan Deviations .............................................................30 
13.9 
Medical Monitoring .........................................................................................31 
14 
STUDY DEVICE .......................................................................................................31 
14.1 
Device Deficiencies .........................................................................................31 
14.2 
Device Accountability .....................................................................................31 
14.2.1 
Receipt of Study Device ...................................................................31 
14.2.2 
Storage ..............................................................................................31 
14.2.3 
Accountability ...................................................................................31 
15 
STATISTICAL PLAN ...............................................................................................31 
15.1 
Sample Size ......................................................................................................32 
15.2 
Outcome Measures...........................................................................................32 
15.2.1 
Primary Endpoint ..............................................................................32 
15.2.2 
Secondary Endpoint ..........................................................................32 
15.2.3 
Safety Measures ................................................................................32 

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15.3 
Analysis Populations ........................................................................................32 
15.4 
Protocol Analysis Exclusions ..........................................................................33 
16 
STUDY MANAGEMENT .........................................................................................34 
16.1 
Investigator Responsibilities ............................................................................34 
16.1.1 
Investigator Agreement .....................................................................34 
16.1.2 
Institutional Review Board ...............................................................34 
16.1.3 
Informed Consent..............................................................................34 
16.1.4 
Study Files and Record Retention.....................................................35 
16.1.5 
Regulatory Compliance ....................................................................35 
16.2 
Sponsor Responsibilities ..................................................................................35 
16.2.1 
Amendments to the Clinical Investigation Plan ................................35 
16.2.2 
General Responsibilities ...................................................................35 
16.3 
Joint Investigator-Sponsor Responsibilities .....................................................35 
16.3.1 
Training .............................................................................................35 
16.4 
Collecting and Recording Data ........................................................................35 
16.4.1 
Source Documents ............................................................................36 
16.4.2 
Case Report Forms ............................................................................36 
16.5 
Protocol Compliance ........................................................................................36 
16.6 
Termination of the Study .................................................................................36 
16.7 
Publication Policy ............................................................................................36 
17 
REFERENCES ...........................................................................................................38 
18 
INVESTIGATOR SIGNATURE ..............................................................................40 
 
 
List of Tables 
Table 7-1: 
Primary Endpoint Acceptance Criteria ............................................................19 
Table 7-2: 
Secondary Endpoint Acceptance Criteria ........................................................19 
Table 13-1: 
Venipuncture Adverse Event Frequency .........................................................25 
Table 13-2: 
Apheresis Adverse Event Frequency ...............................................................26 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
AABB 
American Association of Blood Banks 
ACD-A 
Anticoagulant Citrate Dextrose, Solution A 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CTA 
Clinical Trial Agreement 
CV 
Coefficient of Variation 
DCF 
Data Clarification Form 
DVT 
Deep Venous Thrombosis 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation  
IRB 
Institutional Review Board 
ISO 
International Standard 
ITT 
Intent-to-Treat Population 
Kg 
Kilogram(s) 
L 
Liter(s) 
LOC 
Loss of Consciousness 
LRS 
Leukoreduction system 
MedDRA 
Medical Dictionary For Regulatory Activities 
mL 
Milliliter(s) 
mmHg 
Millimeter of Mercury 
MNC 
Mononuclear Cell 
PHI 
Protected Health Information 
PIR 
Platelet Inventory Recovery 
RBC 
Red Blood Cell 
RPM 
Revolutions Per Minute 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
TA-GvHD 
Transfusion Associated Graft-versus-host Disease 
TBV 
Total Blood Volume 

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TRIM 
Transfusion-related Immunomodulation 
UADE 
Unanticipated Adverse Device Effect 
UCL 
USID 
Upper Confidence Limit 
Unique Study Identification 
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, or chemotherapy, and in individuals that are 
thrombocytopenic (have low platelet count) or have other platelet dysfunctions.  
Currently, the majority of platelets transfused in the United States are collected by apheresis and 
are routinely collected and stored for transfusion in 100% donor plasma.1 The platelets collected 
by apheresis are separated from donor blood using advanced techniques and the remaining blood 
components (red blood cells [RBC], white blood cells [WBC] and/or plasma) can be cycled back 
to the donor. The use of platelet concentrates obtained from single donors by automated 
apheresis has grown steadily as the collection instruments have improved to enable collection of 
double or even triple doses of platelets (hyperconcentrated) in a single apheresis collection. This 
practice maximizes the amount of platelets collected from each donor in a manner that is time 
and cost efficient, and it has the benefit of exposing the recipient to as few individual donors as 
possible, thereby potentially minimizing the risk of transfusion related adverse events (AEs) such 
as pathogen transmission and immune reactions.2  
The risks posed by WBCs in transfused blood components are recognized as an additional and 
substantial problem in transfusion medicine. Residual WBCs in blood components have been 
implicated in transfusion complications, including transfusion associated graft-versus-host 
disease (TA-GvHD), alloimmunization, febrile nonhemolytic transfusion-reactions, transmission 
of intracellular viruses (eg, cytomegalovirus, human immunodeficiency virus [HIV]), and 
transfusion-related immunomodulation (TRIM). To reduce the risk of WBC induced transfusion 
complications, leukoreduction is employed and removes the majority of WBCs from blood 
component products such as hyperconcentrated platelets.3,4 
2 
DEVICE DESCRIPTION 
Terumo BCT, Inc. (Terumo BCT) is a corporation that develops and markets the Trima Accel® 
Automated Blood Collection system (Trima Accel system), an apheresis medical device for the 
collection of blood products, including platelets. The Trima Accel system is an automated blood 
component collection system that uses centrifugal force to separate donor blood into platelet, 
plasma, and RBC components using Anticoagulant Citrate Dextrose, Solution 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.  

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The Trima Accel system consists of a functionally closed disposable set (sterile, nonpyrogenic) 
used in conjunction with equipment and software to collect combinations of blood products. 
Collections for this study will be performed per the Version 6.0 Trima Accel Operators Manual 
and the Version 7.0 user change summary which is provided to the study site by the Sponsor. 
The Trima system 4.0 was initially cleared for the collection of platelets by the FDA on 
13 October 1998 (BK970023). The Trima Accel system was cleared under BK010046 and 
BK010050 and additional Trima Accel embedded software modifications have been submitted 
and cleared by the FDA with the most recent approval on 29 August 2014 (BK140158) for 
Version 6.4 software. 
Terumo BCT has developed new Trima Accel embedded software (ie, Version 7.0) to enhance 
the collection of platelets stored in 100% plasma. 
2.1 
Version 7.0 Software 
The Trima Accel system Version 7.0 software is intended to consolidate multiple enhanced 
software versions with the additional value of creating improvements relevant globally. These 
improvements include, enhancing the leukoreduction, reducing the procedure time, and 
improving the overall experience for the operator and donor.  
The configuration of the device (software update to Version 7.0) will be provided to the 
Investigator by Terumo BCT. These configurations will be within the normal operating range of 
the Trima Accel system Version 6.4, as cleared by the FDA. The operating range for the system 
flow rates, anticoagulant ratios, storage conditions, and centrifugal forces are the same as the 
currently cleared Trima Accel system software. 
The following modifications have been made in Version 7.0 software to be used with the Trima 
Accel system: 
1. The blood prime procedure has been modified to increase the inlet pump speed during 
specific portions of prime, allowing the system to reduce the time of the blood prime 
procedure by improving the blood flow rates through the channel during the priming 
process. 
2. Modifications to the leukoreduction system (LRS) chamber clearing procedure to clear 
excess WBC content from the LRS chamber in a more efficient manner. 
3. Changes to the platelet inventory recovery (PIR) phase to reduce the platelet inventory in 
the separation channel and LRS chamber at the end of the procedure when sufficient 
platelets remain. 

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4. The platelet collection algorithm has been modified to improve the control of the 
concentration of platelets delivered to the LRS separation chamber, thereby improving 
the leukoreduction potential of the LRS chamber. 
5. The platelet collection algorithm for hyperconcentrated platelets has been modified to 
improve the control of the concentration of platelets within the LRS separation chamber, 
also improving the leukoreduction potential of the LRS chamber. 
6. Improvements to the venous access pressure monitoring algorithms have been made that 
adjusts the draw flow rate in response to a venous access alarm (autoflow). Specifically, 
this algorithm allows for longer pump pauses in response to a venous access alarm by 
automatically lowering the flow rate and will automatically increase the flow rate when 
no venous access alarms occur. 
7. Maintenance modifications to the software to upgrade the operating system from 
VxWorks 5.5 to VxWorks 6.9. 
2.2 
Arm Cuff 
It is standard practice during phlebotomy to use a tourniquet or blood pressure cuff 
approximately 2 inches above the antecubital area for venipuncture.5 The American Association 
of Blood Banks (AABB) recommends applying 60 mmHg of pressure either via a tourniquet or 
blood pressure cuff and have the donor squeeze a hand-gripper several times and hold during the 
process of obtaining venipuncture.5 After venipuncture, it is recommended to have the donor 
relax their hand and give the gripper a slow, firm squeeze every 5-10 seconds and loosen the 
tourniquet or blood pressure cuff to 40 mmHg.5 In regards to the apheresis procedure, the AABB 
recommends sites follow their standard operating procedures (SOPs), which generally state to 
maintain appropriate pressure (20 to 40 mmHg) and blood flow (ie, squeeze a hand-gripper) 
during the apheresis procedure.  
Terumo BCT has developed an arm cuff which can be used as an alternative to maintain pressure 
on the arm and blood flow during apheresis procedures. Specifically, this arm cuff has a pressure 
control valve which allows the cuff to be fully inflated for use in obtaining venipuncture, an 
inline relief valve which allows the cuff to maintain the desired donation pressure (20 to 
40 mmHg), and an inflation bulb which the donor may squeeze to maintain the donation 
pressure.  
The arm cuff is not connected or linked to the Trima Accel system and will be submitted for FDA 
clearance as a standalone device as an alternative method to the standard methods of maintaining 
arm pressure and blood flow for apheresis procedures. In the current study, half the study sites 
will receive the arm cuff and the remaining will utilize their standard method of maintaining 

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donation pressure as indicated by the Site SOP. The use of the arm cuff is not expected to impact 
the leukoreduction, volume, or yield of single, double or triple platelet products.  
2.3 
Disposable Sets 
The collection of single, double, and triple platelets in plasma will be done with the Trima Accel 
Platelet, Plasma Set (catalog number 80300). This disposable set was cleared by the FDA 
(BK110009) on 31 May 2011. 
3 
INTENDED USE STATEMENT 
The Trima Accel system is an automated blood cell separator intended for use in collecting blood 
components for later transfusion into patients. Depending on the tubing set used, the Trima Accel 
system may collect multiple blood components, alone or in combination. For the purposes of this 
study the following products will be collected under this protocol: 
• Platelets Pheresis, Leukocyte Reduced in 100% plasma (single, double, and triple units) with 
or without concurrent plasma. 
4 
NONCLINICAL STUDIES 
Laboratory assessments using human and bovine whole blood pools to test software changes 
related to procedure time and platelet leukoreduction have been conducted at Terumo BCT. 
Specifically, modifications to previously released versions of Trima Accel software regarding the 
blood prime and the PIR algorithm have been tested to confirm the software changes in 
Version 7.0 maintain product volume accuracy and reduce the overall time of the apheresis 
procedure. These software modifications tested in whole blood pools resulted in a product 
volume accuracy ± 6% indicating the system was properly primed for the collection procedure 
and decreased the overall procedure time. 
5 
CLINICAL TRIAL EXPERIENCE 
The software modifications being proposed in Trima Accel Version 7.0 software have been 
studied alone and in combination from clinical donations from healthy donors. Software changes 
made to previously released software versions were tested to determine if the additional 
Version 7.0 software modifications resulted in improved leukoreduction, maintained platelet 
yield, and decreased procedure time.  
5.1 
Standard Platelet Leukoreduction Improvements 
Changes to the platelet collection algorithm were tested in blood donations from healthy 
volunteers to determine if software modifications resulted in improvements to the platelet 
leukoreduction in standard platelet products. When collecting standard platelet product (n = 36) 
with the modified algorithm, all of the standard products contained < 5.0 × 106 WBCs per 

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transfusable dose. This modified algorithm was also assessed in combination with the additional 
Version 7.0 software modification. All (100%) of the standard platelet products (n = 30) 
contained < 5.0 × 106 WBCs per transfusable dose. 
5.2 
Platelet Yield and Procedure Time Improvements 
The Trima Version 7.0 software has been modified to improve the overall platelet collection 
procedure time by modifications to the disposable set priming procedure, the LRS chamber 
purge process, and the PIR phase of the collection. Changes to the prime procedure alone 
(n = 52), resulted in a product volume accuracy ± 6% and when tested with other Version 7.0 
enhancements (n = 40) platelet concentrations in the plasma product averaged 5 × 103 cells/uL. 
The venous access monitor has been modified to adjust the draw flow rate in response to venous 
access alerts (autoflow). A clinical assessment of the autoflow algorithm paired with the arm cuff 
(n = 30) resulted in the average operator intervention per procedure being 0.433 ± 0.935. An 
additional study was conducted with the autoflow paired with the Version 7.0 software 
modifications and showed an average operator intervention rate of 0.50 ± 0.88 per procedure. 
These modifications are a significant improvement over the United States average of access 
related events (approximately 5 per procedure as determined by Terumo BCT historical data). 
The LRS chamber purge modifications and the PIR phase modifications resulted in 3-5 minutes 
of time advantage over the current Trima Accel collection for each algorithm respectively. There 
is an even greater time savings advantage for runs where 1 or more purges are saved due to LRS 
chamber purge changes. The time savings due to PIR software modifications are dependent on 
the donor size and precount on the day of donation and therefore may differ per donation. 
When the system leukoreduction performance was measured with the new PIR phase in 
aggregate with additional Version 7.0 software enhancements (n = 30) all (100%) of the products 
contained < 5.0 × 106 WBCs per transfusable dose indicating the time savings do not result in an 
increase in the presence of residual WBCs. 
6 
RATIONALE FOR THE CURRENT STUDY 
The study is designed to evaluate changes to the Trima Accel software (Version 7.0) to ensure 
they meet the FDA acceptance criteria for leukoreduction6,7 (< 5.0 × 106 WBC per transfusable 
unit) and results in platelet yields ≥ 3.0 × 1011 for singles, ≥ 6.2 × 1011 for doubles, and 
≥ 9.3 × 1011 for triples. 
The operating range for the system flow rates, anti-coagulant ratios, storage conditions, and 
centrifugal forces are the same as the currently FDA cleared Trima Accel system. There are no 
changes to the environment or storage conditions for platelets therefore no platelet quality data 
will be evaluated. Additionally, no products will be transfused from this study. 

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The Trima Accel system Version 7.0 software is intended to consolidate multiple enhanced 
software versions with the additional value of creating improvements relevant globally. This 
effort will yield a software release with several new enhancements targeted at improving 
productivity, leukoreduction and WBC flagging, reducing procedure time, reducing venous 
access alarms, and improving the user and donor experience.  
7 
ENDPOINTS 
7.1 
Primary Endpoint 
The proportion of platelet units with an acceptable residual WBC level. Acceptable WBC levels 
for single, double, and triple platelet products are presented in Table 7-1. 
Table 7-1: Primary Endpoint Acceptance Criteria 
Parameter 
Measured 
Acceptance Criteria 
Residual WBC Count 
– Single Unit 
Flow cytometry; BD 
LeukocountTM or equivalent 
Residual WBC count is 
< 5.0 × 106   
Residual WBC Count 
– Double Unit 
Flow cytometry; BD 
Leukocount or equivalent 
Residual WBC count is 
< 8.0 × 106 or each 
component < 5.0 × 106 
Residual WBC Count 
– Triple Unit 
Flow cytometry; BD 
Leukocount or equivalent 
Residual WBC count is 
< 12.0 × 106 or each 
component < 5.0 × 106 
Abbreviations: WBC = white blood cell 
7.2 
Secondary Endpoint 
The proportion of platelet units with an acceptable platelet yield. Acceptable platelet yield for 
single, double and triple platelet products are presented in Table 7-2.  
Table 7-2: Secondary Endpoint Acceptance Criteria  
Parameter 
Measured 
Acceptance Criteriaa 
Platelet yield – Single Unit 
Platelet concentration × 
volume 
Platelet yield is ≥ 3.0 × 1011  
Platelet yield – Double 
Unit 
Platelet concentration × 
volume 
Platelet yield is ≥ 6.2 × 1011 
Platelet yield – Triple Unit 
Platelet concentration × 
volume 
Platelet yield is ≥ 9.3 × 1011 
a These yields represent typical lab minimums for splitting into double and triple platelet 
products. 

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7.3 
Safety Measures 
Safety will be monitored through collection of AEs, serious adverse events (SAEs), and 
unanticipated adverse device effects (UADEs).  
8 
INVESTIGATIONAL PLAN 
8.1 
Study Design 
This is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of 
platelets stored in 100% plamsa collected on the Trima Accel system with Version 7.0 software 
enhancements. Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 single, 
93 double, and 93 triple platelet product evaluable data points. Evaluable is defined as a 
completed platelet product that does not meet any of the protocol analysis exclusion criteria 
(Section 15.4).  
The additional subjects account for screen failures, incomplete procedures, and protocol analysis 
exclusions. 
Concurrent plasma will be collected from qualifying subjects to exercise the platelet/plasma 
product combination. Of the 93 evaluable procedures required for each type (singles, doubles, 
and triples) at least 25% of collections will include concurrent plasma collection. The Trima 
Accel system calculates subject eligibility for blood product combinations based on platelet 
count, hemoglobin or hematocrit, and total blood volume (TBV) of the subject.  
Red blood cells will not be collected in this study; platelets will be collected in 100% plasma. 
The Trima Accel system collects RBCs after platelets and plasma, therefore there is no effect of 
RBC collections on the platelet collections due to platelet collection software modifications. 
Similarly, there is no effect of the platelet collections on subsequent RBC collections.  
8.2 
Study Duration 
Study participation will be up to 30 days and will consist of 1 or 2 visits. Screening may be done 
within 30 days of 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, 
dependent upon the product to be collected, machine configuration, subject parameters, the 
quality of the vascular access, and the tolerance of the subject to the ACD-A anticoagulant.  
The entire study should be completed in approximately 16 months. 

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9 
STUDY POPULATION 
9.1 
Number of Subjects and Selection 
Up to 350 healthy volunteer donors will be enrolled in this study in at least 2 and up to 
8 investigative 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. The subjects who participate in this 
research will have no direct benefit. Subjects will be recruited in a non-coercive manner and 
recruitment will be irrespective of ethnicity or gender. 
9.2 
Inclusion Criteria 
1. Age 18 years or older. 
2. Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with 
plasma collection on the Trima Accel system. These criteria are based on FDA 
Regulations and AABB standards. Note: Subjects who are deferred from volunteer 
community donations because of travel restrictions, piercings, or tattoos may participate 
in the study, as products are not transfused. 
3. Has given written informed consent 
9.3 
Exclusion Criteria 
1. Has previously donated an evaluable platelet product in this study (CTS-5060). 
9.4 
Enrollment 
 A donor is considered to be an enrolled subject following informed consent. It is expected that, 
due to the screening and eligibility requirements, some fraction of subjects will not qualify for a 
platelet/plasma donation after consent and some who are enrolled may not complete their 
anticipated procedures. Subjects will be considered screen failures if they fail to meet any of the 
eligibility criteria, and subjects who do not complete their anticipated procedure (after 
venipuncture) will be considered as an early termination. 
After informed consent has been obtained, subjects will receive a unique study identification 
number (USID). The USID number will use the following convention: 60XX-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).   
Subjects that fail screening criteria on information or laboratory values that are anticipated to 
change, may be rescreened. Subjects that have incomplete procedures or donated a product that 
meets any of the protocol analysis exclusions (Section 15.4) may rescreen if they meet all 

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inclusion criteria when they return. Subjects that are rescreened will be assigned a new USID 
number. 
10 
STUDY PROCEDURES 
10.1 
Screening (Days -30 to 1) 
Screening can be performed within 30 days before the apheresis procedure or combined with the 
Day 1 Apheresis Visit.  
The following evaluations will be performed: 
1. Informed consent will be obtained prior to initiating any study specific procedures. 
2. Eligibility will be confirmed. 
3. Demographics (age, gender, ethnic origin), height, weight, and donor identification 
number will be collected. 
4. Venipuncture will be conducted for hemoglobin or hematocrit and platelet count on 
subjects who are new to the Site and who do not have recent and/or historical hemoglobin 
and/or platelet count measurements. 
5. Record any AEs and SAEs. 
10.2 
Day of Apheresis (Day 1) 
10.2.1 
Prior to Apheresis 
1. Finger stick for hemoglobin or hematocrit testing. 
10.2.2 
Apheresis Procedure 
Plateletpheresis will be per site standard practice and per applicable FDA guidelines such as the 
“Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods, 
December 2007” and the “Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole 
Blood and Blood Components Intended for Transfusion, September 2012”.6,7  
Apheresis procedures will be run according to the instructions and precautions described in the 
Version 6.0 Trima Accel Operator’s Manual and the Version 7.0 user change summary. 
The following procedures will be performed: 
1. Venipuncture.  
2. Collect venous whole blood sample. 
a. Complete blood count (hemoglobin or hematocrit and platelet count). 
3. Update Trima Accel device with updated platelet count and hemoglobin or hematocrit. 

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4. Perform apheresis procedure. 
5. Record the following: 
a. Type of cuff used. 
b. Trima procedure details. 
c. AEs, SAEs and UADEs. 
d. Medical interventions to treat AEs, if applicable. 
e. Device deficiencies. 
This will conclude the subject’s participation. 
10.2.3 
Data from Collected Platelet and Plasma Products 
1. Platelet Product 
a. Dilution factor 
b. Residual WBC count. 
c. Complete blood count test (platelet count). 
d. Product weight. 
2. Plasma Product 
a. Residual WBC count. 
b. Complete blood count tests (platelet count and RBC count). 
c. Product weight. 
10.3 
Study Procedure Discontinuation/Termination 
All subjects are free to withdraw from participation in this study at any time, for any reason, 
specified and unspecified, and without prejudice. The reason for the subject discontinuing study 
treatment or terminating from the study will be recorded on the Source Documents (SD) and 
eCRF. 
Reasons for study termination include: 
1. Development of an AE that interferes with the subject’s continued participation. 
2. Subject refuses further treatment and/or follow-up and withdraws consent. 
3. After receiving platelet count based on the venous sample, a subject qualifies for a study 
procedure which has already reached its target enrollment (ie, testing indicates the subject 
qualifies for single platelet donation; however, 93 subjects have already completed the 
single platelet product donation). 

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4. Investigator decision. 
5. Sponsor decision. 
6. Subject is lost to follow-up. 
7. Subject death. 
11 
LABORATORY TESTS 
Laboratory tests will be analyzed locally at each study site. Copies of the current laboratory 
certifications and normal ranges will be provided to Terumo BCT prior to start of the study and 
upon every renewal throughout the duration of the study. 
12 
CONCOMITANT MEDICATIONS 
Medications administered to treat AEs will be recorded on the site source documents and eCRFs. 
13 
ADVERSE EVENTS/EFFECTS 
13.1 
Anticipated Risks 
13.1.1 
Potential Apheresis Related Risks 
Donor reactions are mostly transient self-limited events, and in very rare exceptions a donor may 
experience long-term morbidity or sustain permanent impairment.8,9 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.9-11 Although rare (< 5 out of 10,000 apheresis donations), almost 40% of reactions 
requiring medical care outside the donation premises are venipuncture related, including large 
hematoma, and possible nerve irritation.11 
13.1.2 
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 13-1. 

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Table 13-1: 
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 
General8,10-12 
Apprehension 
 
Presyncopea 
 
Faintb 
 
 
 
At puncture 
site8,10,11,14 
 
Hematoma 
 
Nerve 
irritation 
Arterial 
puncture 
 
Pain 
Infection 
Distant of 
puncture 
site8,9,11,13 
 
Discomfort 
 
 
Skin allergy 
Phlebitis 
Neuropathic 
pain 
 
DVT 
Abbreviations: DVT = deep venous 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. 
13.1.3 
Apheresis Complications in Healthy Donors  
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 
15 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.14-16 Mild citrate reactions are very common with apheresis procedures, while 
vasovagal reactions are substantially lower compared to whole blood donation.11,14 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 13-2 are general apheresis risks and are not 
specific to the Trima Accel system. 

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Table 13-2: 
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 
Reactions10,11, 
14,17 
 
Paresthesia 
Nausea 
Vomiting 
Tetany 
Arrhythmia 
Cardiac arrest 
Lightheadedness 
Cramps 
Seizure 
Metallic taste 
Spasms 
Chills 
Vasovagal 
Reactionsa 11,14 
 
 
Presyncopeb 
Vomiting 
Convulsion 
LOC with 
trauma injury  
 
Weakness 
Hypotension 
Seizure 
Syncope 
Bradycardia 
Other Notable 
Events10,11,14,18 
 
 
 
 
 
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. 
13.1.4 
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, Terumo BCT has no knowledge that any such event has occurred with the Trima Accel 
system to date. 
13.2 
Risk Mitigation 
To minimize risks of subject 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 Subject Protection, and Clinical 
Investigation Plan (CIP) training to include device and procedure training.  

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2. Ensuring that subjects who are enrolled meet all eligibility criteria, including minimum 
hemoglobin or hematocrit and platelet limits for donation. The apheresis devices are 
programmed to allow collection of products only from subjects who will meet projected 
hematocrit and platelet standards at the completion of the collection. These limitations are 
for the safety of subjects and apply to this protocol. 
3. Stopping the procedure if moderate or severe AEs occur. The subject 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. Electronic CRFs will be 
uploaded to the electronic data capture (EDC) with only subject and product number as 
subject identifiers, to ensure confidentiality. 
5. Subjects will be questioned concerning adverse experiences throughout the procedure. 
Subjects will also be visually monitored for signs of distress during blood donation. 
Suspected adverse reactions will be treated according to study sites’ SOPs and 
documented on the SD and eCRFs.  
13.3 
Adverse Event Definitions 
An AE is defined as any untoward medical occurrence in a clinical investigation subject, 
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. 
13.4 
Adverse Event Recording 
Adverse events that occur after signing the informed consent form (ICF) will be recorded on the 
AE eCRF.  
13.5 
Adverse Event Reporting 
13.5.1 
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. 

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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. 
13.5.2 
Relationship 
The Principal Investigator (PI) 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 
subject’s clinical state. 
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 subject’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 subject’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. 
13.6 
Adverse Event Follow-up 
All treatment-related AEs must be followed in accordance with the International Conference of 
Harmonization (ICH) Good Clinical Practice (GCP) guidelines, and other applicable regulatory 

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requirements (e.g., US Code of Federal Regulations [CFR] 812). The expected AE of mild 
hematoma (bruise) and/or mild infiltration are not followed to resolution.  
13.7 
Serious Adverse Events and Unanticipated Adverse Device Effect 
13.7.1 
Definition 
In the interest of subject care and to allow Terumo BCT to fulfill all regulatory requirements, any 
SAE and/or UADE, regardless of causal relationship to study treatment/procedure(s), must be 
reported to Terumo BCT within 24 hours of knowledge of the event. 
SAEs are defined (21 CFR 312.32 and ISO 14155:2011 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 subject, that either resulted in  
• A life-threatening illness or injury, or  
• A permanent impairment of a body structure or a body function, or  
• Inpatient or prolonged hospitalization, or  
• 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 a serious adverse event. 
Unanticipated adverse device effect (UADE): per 21 CFR 812.3 a 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 operators manual, or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. 
NOTE: Anticipated adverse device effects are effects, which by nature, incidence, severity or 
outcome have been identified in the CIP and/or Trima Accel operators manual. 

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13.7.2 
SAE/UADE Reporting 
Any AE/SAE/UADE that occurs after signing the ICF 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 Terumo BCT within 24 hours of 
knowledge of the event to: 
Terumo BCT 
Email: ClinicalAffairs@TerumoBCT.com 
Fax: (303) 876-9146 
Terumo 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 CRF. Follow-up 
SAE/UADE reports need to be submitted to Terumo BCT as soon as additional information 
regarding the event becomes available. 
Terumo BCT 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: 
• 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. 
13.8 
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. 
All CIP deviations will be reported to the Sponsor. Protocol deviations that may affect the 
scientific soundness of the study or affect the rights, safety, or welfare of study subjects, must be 
reported to the Sponsor and the IRB as per the IRB’s standard reporting procedure. 

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13.9 
Medical Monitoring 
It is the responsibility of the PI to oversee the safety of the study at his/her site. There will not be 
a Data Safety Monitoring Board for this study because it involves healthy subjects undergoing a 
commonly practiced research evaluation procedure. 
Terumo BCT will monitor the safety of the study subjects on an ongoing basis.  
14 
STUDY DEVICE 
14.1 
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. 
14.2 
Device Accountability 
14.2.1 
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. 
14.2.2 
Storage 
The device and 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. 
14.2.3 
Accountability 
The Trima Accel device, disposables, arm cuff and software will be provided by Terumo BCT for 
use in this study. The Trima Accel disposables are FDA cleared and marketed in the United 
States. 
15 
STATISTICAL PLAN 
The following section summarizes the statistical methods that will be used in the analysis of the 
clinical data from this active-controlled trial. Continuous variables will be described using 
means, medians, and measures of dispersion including standard deviation and ranges with 
categorical variables will be summarized with frequencies and percentages. 

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15.1 
Sample Size 
As specified in the FDA guidance, for up to 1 allowed failure, 93 platelet products are required to 
show that the proportion of platelet units with an acceptable residual WBC level is at least 95% 
with 95% confidence. 9 With 93 platelet products being collected, 16 failures or less is required 
to show that the proportion of platelet units with an acceptable platelet yield is at least 75% with 
95% confidence. 
15.2 
Outcome Measures 
15.2.1 
Primary Endpoint 
The primary endpoint for this study is the proportion of platelet units with an acceptable residual 
WBC level. Counts and percentages of success rates and the lower one-sided 95% exact 
binomial confidence intervals will be calculated separately for success rates of single, double, 
and triple platelet products. If 0 or 1 failure is observed, then the confidence interval will suggest 
that the true success rate is at least 95% with 95% confidence for the given platelet product. This 
approach will be applied independently to single, double, and triple platelet products. 
15.2.2 
Secondary Endpoint 
The secondary endpoint of platelet yield will be summarized for single, double, and triple 
platelet products. Separately for single, double, and triple platelet products, the lower one-sided 
95% exact binomial confidence intervals will be calculated for the proportion of platelet units 
with an acceptable platelet yield. If 16 or fewer failures are observed, then the confidence 
interval will suggest that the true success rate is at least 75% with 95% confidence for the given 
platelet product.  
15.2.3 
Safety Measures 
Adverse events will be summarized by the medical dictionary for regulatory activities (MedDRA 
Version 18.1 or later). Tables will describe the frequency and percentage of all AEs, SAEs, and 
UADEs reported by subjects in the safety population. Presentations will summarize AEs by 
maximum reported severity and relationship to device and procedure. AEs leading to study or 
procedure discontinuation will also be tabulated.  
15.3 
Analysis Populations 
The safety population will include of all subjects enrolled in this trial for whom at least 1 
apheresis procedure is initiated. The Full Analysis Set (FAS) will be defined separately for 
single, double, and triple platelet products. The FAS for a given platelet product will consist of 
the first 93 collections that do not meet any of the protocol exclusion criteria described in Section 
15.4. The FAS will be used to examine the primary and secondary endpoints. 

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15.4 
Protocol Analysis Exclusions 
Data points will be excluded from analysis in the following situations: 
1. Inability to collect a complete unit due to: 
a. Subject issues (inadequate access, reaction, needle abort, procedure 
disqualification upon Trima Accel device update of subject platelet count and 
hemoglobin or hematocrit). 
b. Decision to stop procedure by subject, Investigator, nursing staff or operator. 
c. Equipment failure or malfunction (unrecoverable system failure; plugged or 
malfunctioning filter[s]). 
d. Protocol deviation. 
2. Decision to stop the procedure due to a change in the subject platelet count (ie subject 
qualifies for double, however day-of platelet count is for a single platelet product and 93 
single platelet products have already been collected). 
3. Failure or inability to update the Trima Accel system with the actual platelet count 
(platelet count performed on sample taken from Trima Disposable sample pouch) AND 
the actual platelet count differs from the entered platelet count by more than 10%. 
Updating the Trima Accel system with actual platelet count from the sample pouch is 
standard procedure for the Trima Accel system.  
4. Incomplete or incorrect collection procedure or post-collection processing due to: 
a. Equipment failure or malfunction. 
b. Subject issues (inadequate access, reaction, needle abort). 
c. Unanticipated centrifuge stop during collection procedure. 
d. Failure to follow collection or post-collection handling procedure outlined in the 
Trima Operator’s Manual, and supplement(s). 
e. Subject and procedure samples are not taken as specified in protocol. 
f. Incorrect solution added to platelets prior to storage (eg platelet additive solution). 
g. Results of endpoint assays are not available. 

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16 
STUDY MANAGEMENT 
16.1 
Investigator Responsibilities 
16.1.1 
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.  
16.1.2 
Institutional Review Board 
The IRB or other committee functioning in a similar capacity will review and approve the 
protocol and any protocol 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 Terumo BCT before any subject is enrolled into this 
study. 
16.1.3 
Informed Consent 
The Investigator is responsible for preparing the written IC document for this study. Terumo 
BCT 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 subject participation in this study, the Investigator must obtain written IRB approval for 
the protocol and the ICF. The approved consent form will clearly reflect the IRB approval date.  
Once the subject’s initial eligibility has been determined, the Investigator or person designated 
by the Investigator, who has been trained on the protocol, will explain the nature and scope of the 
study, potential risks and benefits of participation, answer questions for the subject and ask the 
subject to participate in the study. The study will be explained to the study subject in lay terms, 
in their native language in a quiet, non-disruptive setting. Potential subjects 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 subject 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 subject agrees to participate, the subject has read the ICF, and has had all of their questions 
answered, then the ICF must be signed and personally dated by the subject and the person 
completing the consent process. A copy of the signed and dated ICF will be provided to the study 
subject.  
All subjects 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 subject discontinuing or 
terminating from the study must be recorded on the eCRF. 

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16.1.4 
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.  
16.1.5 
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. 
16.2 
Sponsor Responsibilities 
16.2.1 
Amendments to the Clinical Investigation Plan 
Any amendment to the protocol, as deemed appropriate by Terumo BCT, will be implemented as 
the study progresses. Amendments will be submitted to the IRB for written approval, before 
implementation.  
16.2.2 
General Responsibilities 
As per ISO 14155 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/EC and government authorities as well as annual reports as 
required.  
16.3 
Joint Investigator-Sponsor Responsibilities 
16.3.1 
Training 
The Sponsor will train applicable study team members as to the device, protocol, 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.  
16.4 
Collecting and Recording Data 
The Investigators will maintain complete, accurate, legible, and easily retrievable data, and will 
allow personnel authorized by Terumo BCT 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.  
16.4.1 
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. 
16.4.2 
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 CRA will verify the EDC 
data with the subject’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 subject must be completed in a timely manner. 
16.5 
Protocol Compliance 
The Investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol  
16.6 
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, Terumo BCT may terminate the study at 
any time upon immediate notice for any reason, including but not limited to, Terumo BCTs’ 
belief that termination is necessary for the safety of subjects or failure to meet the primary 
endpoints. 
16.7 
Publication Policy 
Terumo BCT 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 Terumo BCT for timely review in accordance 
with the terms of the CTA between the Investigator, the Institution, and Terumo BCT. Terumo 
BCT shall not, in its scientific publications or promotional material, quote from publications by 
Investigators without full acknowledgment of the source. As this will be a multi-site study, all 

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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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17 
 REFERENCES 
1. Jaben EA, Gandhi MJ. The post-platelet 100,000 count: Effects of platelet collection and 
future. Journal of clinical apheresis 2011;26(1):53-5. 
2. Ness PM, Campbell-Lee SA. Single donor versus pooled random donor platelet 
concentrates. Current opinion in hematology 2001;8(6):392-6. 
3. Akahoshi M, Takanashi M, Masuda M, et al. A case of transfusion-associated graft-
versus-host disease not prevented by white cell-reduction filters. Transfusion. 
1992;32(2):169-172. 
4. Hayashi H, Nishiuchi T, Tamura H, Takeda K. Transfusion-associated graft-versus-host 
disease caused by leukocyte-filtered stored blood. Anesthesiology. 1993;79(6):1419-
1421. 
5. American Association for Blood Banks. Donor Services Training Manual. September 
2012. 
6. Center for Biologics Evaluation and Research. Guidance for Industry: Pre-Storage 
Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion. 
September 2012. 
7. Center for Biologics Evaluation and Research. Guidance for Industry and FDA Review 
Staff: Collection of Platelets by Automated Methods. December 2007. 
8. Sorensen BS, Johnsen SP, Jorgensen J. Complications related to blood donation: a 
population-based study. Vox sanguinis. Feb 2008;94(2):132-137. 
9. Gavillet M, Tissot JD, Canellini G. Blood donation associated risks: data from a Swiss 
regional haemovigilance program. Transfusion medicine. Aug 2013;23(4):269-271. 
10. Danic B, Lefort C. Effets indésirables donneurs et leur prise en charge. Transfusion 
Clinique et Biologique. Dec 2010;17(5–6):301-305. 
11. Eder AF, Dy BA, Kennedy JM, et al. The American Red Cross donor hemovigilance 
program: complications of blood donation reported in 2006. Transfusion. Sep 
2008;48(9):1809-1819. 
12. Deacon B, Abramowitz J. Fear of needles and vasovagal reactions among phlebotomy 
patients. Journal of anxiety disorders. 2006;20(7):946-960. 
13. Sorensen BS, Jorgensen J, Jensen TS, Finnerup NB. Pain following blood donation: a 
questionnaire study of long-term morbidity (LTM) in blood donors. Vox sanguinis. Mar 
31 2015. 
14. McLeod BC, Price TH, Owen H, et al. Frequency of immediate adverse effects 
associated with apheresis donation. Transfusion. Oct 1998;38(10):938-943. 
15. Wiltbank TB, Giordano GF. The safety profile of automated collections: an analysis of 
more than 1 million collections. Transfusion. Jun 2007;47(6):1002-1005. 

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16. Shehata N, Kusano R, Hannach B, Hume H. Reaction rates in allogeneic donors. 
Transfusion medicine. Oct 2004;14(5):327-333. 
17. Makar YF, Butler MO, Cockersole GM, Gabra G, Serevitch JM. National audit of citrate 
toxicity in plateletpheresis donors. Transfusion medicine. Jun 2002;12(3):187-191. 
18. Nakajima K. Donor complications and donor care. ISBT Science Series. 2009;4(n2):411-
417. 
19. Health, U.S.D.o. and S. Human, Common terminology criteria for adverse events 
(CTCAE). 2012. 
 

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18 
INVESTIGATOR SIGNATURE 
 
Study Title: 
Evaluation of the Performance of Trima Accel® Version 7.0 
Software Enhancements for the Collection of Platelets Stored in 
100% Plasma 
Study Number: 
CTS-5060 
Version/Date: 
Version 3.0/19 FEB 2016 
I have read the clinical investigation plan, including all appendices, and I agree that it contains 
all necessary details for my staff and me to conduct this study as described. I will conduct this 
study in compliance with the clinical investigation plan, Good Clinical Practices, 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 clinical investigation 
plan and grant access to all information provided by Terumo BCT. I will discuss this material 
with all study personnel under my supervision to ensure that they are fully informed about the 
study. 
 
 
Investigator Name (printed) 
 
Signature 
 
 
 
 
 
 
Date