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

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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 
Platelet Additive Solution 
Study Number: 
CTS-5059 
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: 
Heather Pidcoke, MD, PhD  
Phone:  (303) 231-4805 
Email: Heather.Pidcoke@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: 
4.0/22 NOV 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The information contained in this document, particularly unpublished data, is the property or 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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AMENDMENT 3 SUMMARY OF CHANGES 
Study Title: 
Evaluation of the Performance of Trima Accel® Version 7.0 Software 
Enhancements for the Collection of Platelets Stored in Platelet Additive Solution 
CIP #: 
CTS-5059 
CIP Version / Date: 
Version 4.0/22 NOV 2016 
Replaces CIP Version / Date: 
Version 3.0/19 FEB 2016 
Rationale: 
This amendment was made to increase the number of healthy adult subjects 
enrolled in this study from up to 350 subjects to up to 450 subjects. After study 
initiation, it was noted that the number of screen failures and procedures 
excluded per Section 15.4 Protocol Analysis Exclusions was higher than 
originally anticipated. Therefore, in order to ensure 93 evaluable single, double, 
and triple products are collected from 279 individual subjects, the total number 
of subjects enrolled in the study will be increased from up to 350 to up to 450.   
Additionally, typographical error corrections, sponsor contact information, 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 8.1 Study 
Design, and Section 9.1 
Number of Subjects and 
Selection 
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 
Up to 450 healthy adult subjects will be 
enrolled in this study to ensure 93 single, 
93 double and 93 triple platelet product 
evaluable data points 
 

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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 Platelet Additive Solution 
Study Number: 
CTS-5059 
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 three 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 hyperconcentrated platelet collections stored in platelet additive 
solution (PAS) on 17 December 2012 (BK120049). 
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 PAS 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). 
Inclusion Criteria: 
1. Age 18 years or older. 
2. 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 
guidance and 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. 

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Exclusion Criteria: 
1. Has previously donated an evaluable platelet product in this study (CTS-5059). 
Number of Subjects  
Planned: 
Up to 450 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 PAS collected on the Trima Accel system 
Version 7.0 software enhancement. Up to 450 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......................................................................................................11 
1.1 
Background ......................................................................................................11 
2 
DEVICE DESCRIPTION .........................................................................................12 
2.1 
Version 7.0 Software .......................................................................................12 
2.2 
Arm Cuff ..........................................................................................................13 
2.3 
Platelet Additive Solution ................................................................................14 
2.4 
Disposable Sets ................................................................................................15 
3 
INTENDED USE STATEMENT..............................................................................15 
4 
NONCLINICAL STUDIES.......................................................................................15 
5 
CLINICAL TRIAL EXPERIENCE .........................................................................15 
5.1 
Hyperconcentrated Platelet Leukoreduction Improvements ............................16 
5.2 
Platelet Yield and Procedure Time Improvements ..........................................16 
6 
RATIONALE FOR THE CURRENT STUDY .......................................................16 
7 
ENDPOINTS ..............................................................................................................17 
7.1 
Primary Endpoint .............................................................................................17 
7.2 
Secondary Endpoint .........................................................................................17 
7.3 
Safety Measures ...............................................................................................18 
8 
INVESTIGATIONAL PLAN ...................................................................................18 
8.1 
Study Design ....................................................................................................18 
8.2 
Study Duration .................................................................................................18 
9 
STUDY POPULATION ............................................................................................19 
9.1 
Number of Subjects and Selection ...................................................................19 
9.2 
Inclusion Criteria .............................................................................................19 
9.3 
Exclusion Criteria ............................................................................................19 
9.4 
Enrollment........................................................................................................19 
10 
STUDY PROCEDURES ...........................................................................................20 
10.1 
Screening (Days -30 to 1) ................................................................................20 
10.2 
Day of Apheresis (Day 1) ................................................................................20 
10.2.1 
Prior to Apheresis .............................................................................20 
10.2.2 
Apheresis Procedure .........................................................................20 
10.2.3 
Data from Collected Platelet and Plasma Products...........................21 

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10.3 
Study Procedure Discontinuation/Termination................................................21 
11 
LABORATORY TESTS ...........................................................................................22 
12 
CONCOMITANT MEDICATIONS ........................................................................22 
13 
ADVERSE EVENTS/EFFECTS ..............................................................................22 
13.1 
Anticipated Risks .............................................................................................22 
13.1.1 
Potential Apheresis Related Risks ....................................................22 
13.1.2 
Venipuncture Related........................................................................22 
13.1.3 
Apheresis Complications in Healthy Donors ....................................23 
13.1.4 
Apheresis Risks with the Trima Accel System .................................24 
13.2 
Risk Mitigation ................................................................................................24 
13.3 
Adverse Event Definitions ...............................................................................25 
13.4 
Adverse Event Recording ................................................................................25 
13.5 
Adverse Event Reporting .................................................................................25 
13.5.1 
Severity .............................................................................................25 
13.5.2 
Relationship ......................................................................................26 
13.6 
Adverse Event Follow-up ................................................................................26 
13.7 
Serious Adverse Events and Unanticipated Adverse Device Effect ................27 
13.7.1 
Definition ..........................................................................................27 
13.7.2 
SAE/UADE Reporting ......................................................................28 
13.8 
Clinical Investigation Plan Deviations.............................................................28 
13.9 
Medical Monitoring .........................................................................................29 
14 
STUDY DEVICE .......................................................................................................29 
14.1 
Device Deficiencies .........................................................................................29 
14.2 
Device Accountability .....................................................................................29 
14.2.1 
Receipt of Study Device ...................................................................29 
14.2.2 
Storage ..............................................................................................29 
14.2.3 
Accountability ...................................................................................29 
15 
STATISTICAL PLAN ...............................................................................................29 
15.1 
Sample Size ......................................................................................................30 
15.2 
Outcome Measures...........................................................................................30 
15.2.1 
Primary Endpoint ..............................................................................30 
15.2.2 
Secondary Endpoint ..........................................................................30 

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15.2.3 
Safety Measures ................................................................................30 
15.3 
Analysis Populations ........................................................................................30 
15.4 
Protocol Analysis Exclusions ..........................................................................31 
16 
STUDY MANAGEMENT .........................................................................................32 
16.1 
Investigator Responsibilities ............................................................................32 
16.1.1 
Investigator Agreement .....................................................................32 
16.1.2 
Institutional Review Board ...............................................................32 
16.1.3 
Informed Consent..............................................................................32 
16.1.4 
Study Files and Record Retention.....................................................33 
16.1.5 
Regulatory Compliance ....................................................................33 
16.2 
Sponsor Responsibilities ..................................................................................33 
16.2.1 
Amendments to the Clinical Investigation Plan................................33 
16.2.2 
General Responsibilities ...................................................................33 
16.3 
Joint Investigator-Sponsor Responsibilities .....................................................33 
16.3.1 
Training .............................................................................................33 
16.4 
Collecting and Recording Data ........................................................................33 
16.4.1 
Source Documents ............................................................................34 
16.4.2 
Case Report Forms ............................................................................34 
16.5 
Protocol Compliance ........................................................................................34 
16.6 
Termination of the Study .................................................................................34 
16.7 
Publication Policy ............................................................................................34 
17 
REFERENCES ...........................................................................................................36 
18 
INVESTIGATOR SIGNATURE ..............................................................................38 
 
List of Tables 
Table 7-1: 
Primary Endpoint Acceptance Criteria ............................................................17 
Table 7-2: 
Secondary Endpoint Acceptance Criteria ........................................................17 
Table 13-1: 
Venipuncture Adverse Event Frequency .........................................................23 
Table 13-2: 
Apheresis Adverse Event Frequency ...............................................................24 
 

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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 
ELF 
Extended Life Platelet 
ESC 
Extent of Shape Change 
FDA 
United States Food and Drug Administration 
GCP 
Good Clinical Practice 
HIV 
Human Immunodeficiency Virus 
HSR 
Hypotonic Shock Response 
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 
PAS 
Platelet Additive Solution 
PHI 
Protected Health Information 
PIR 
Platelet Inventory Recovery 
RBC 
Red Blood Cell 
RPM 
Revolutions Per Minute 

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SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
TA-GvHD 
Transfusion Associated Graft-versus-host Disease 
TBV 
Total Blood Volume 
TRIM 
Transfusion-related Immunomodulation 
UADE 
Unanticipated Adverse Device Effect 
UCL 
Upper Confidence Limit 
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, 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.1 
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.3,4 
In addition to leukoreduction in platelet products, platelets can be stored in platelet additive 
solution (PAS). In Europe it is common practice to replace part of the plasma with PAS. The 
rationale behind this practice is that diluting the plasma may reduce the risk of deleterious 
reactions such as allergic reactions and immune reactions triggered by cellular mediators present 
in the plasma.5 Substituting PAS for plasma may have other advantages as well. It has a more 
consistent composition than plasma from different donors, it can be optimized for longer storage, 
and it allows for a more frugal use of blood components since more plasma can then be used for 
other applications instead of platelet storage.6,7 
Platelet additive solution has 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 PAS InterSolTM (Fenwal™, a Fresenius Kabi company) as a 
replacement of 65% plasma in platelet components. Subsequently, approval was received in 2012 

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for IsoplateTM solution use with the Trima Accel® Automated Blood Collection system (Trima 
Accel system). 
2 
DEVICE DESCRIPTION 
Terumo BCT, Inc. (Terumo BCT) is a corporation that develops and markets the 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.  
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 PAS. 
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: 

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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. 
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.8 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.8 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.8 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.  

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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 
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 
Platelet Additive Solution 
InterSol solution was FDA approved for the storage of hyperconcentrated platelets (BN080041) 
on 07 December 2009 for use with the AmicusTM Separator system (BK090065). InterSol PAS is 
an isotonic solution designed to replace a proportion (65%) of the plasma used in the storage of 
leukoreduced apheresis platelets under standard blood banking conditions. 
The solution contains constituents that are naturally occurring components present in many 
cellular systems: sodium acetate as a nutrient, sodium citrate to prevent platelet clumping and 
activation, sodium phosphate for buffering, and sodium chloride for osmolarity. InterSol solution 
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. 
InterSol solution is provided as a 500 mL sterile and non-pyrogenic solution in a non-polyvinyl 
chloride plastic container with a sterile and non-pyrogenic fluid path. 
Each 100 mL of InterSol 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. 
Currently, the use of InterSol solution for storage of platelets with the Trima Accel system has 
not been cleared by the FDA. The FDA has recently approved a prospective in vitro study of 
platelets collected on the Trima Accel system and stored in InterSol solution (IDE 16145).  

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2.4 
Disposable Sets 
The collection of single, double, and triple platelets stored in PAS will be done with the Trima 
Accel Platelet + Sampler + AutoPAS, MultiPlasma, RBC disposable set (catalog number 80370). 
This disposable set was cleared by the FDA (BK120049) on 17 December 2012. 
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 65% InterSol PAS (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.   
Additionally, the in vitro quality of double hyperconcentrated platelets collected from a single 
donor on the Trima Accel system, split and then stored in plasma via gravity drain and InterSol 
solution via auto PAS-metering was tested. The acceptance criteria9 of pH(22°C) > 6.2 was met for 
all units in this study through 7 days of storage. In vitro cell quality of platelets stored in InterSol 
solution (determined by extent of shape change [ESC], hypotonic shock response [HSR], 
membrane-bound P-selectin expression [CD62P], and morphology scoring) was robust in 
InterSol solution stored platelets and was comparable to control platelets stored in plasma. 
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.  

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5.1 
Hyperconcentrated 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 hyperconcentrated platelet products. In hyperconcentrated platelet products, 
the modified platelet collection algorithm alone showed an overall system performance of 100% 
of products containing < 5.0 × 106 WBCs per transfusable dose and 99.9% of hyperconcentrated 
products contain < 1.1 × 106 WBCs per transfusable dose per log normal regression analysis. 
When this modification was assessed with additional Version 7.0 enhancements (n = 24), all of 
the hyperconcentrated products 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 and the LRS chamber 
purge process. 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 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. 
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 leukoreduction9,10 (< 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 

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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. 
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 PAS collected on the Trima Accel system with Version 7.0 software 
enhancements. Up to 450 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 65% InterSol 
PAS and 35% 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 450 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 
PAS 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-5059). 
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 a study procedure discontinuation/termination. 
After informed consent has been obtained, subjects will receive a unique study identification 
(USID) number. The USID number will use the following convention: 59XX-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 or 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”.9,10  
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.11,12 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.12-14 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.14 
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 
General11,13-15 
Apprehension 
 
Presyncopea 
 
Faintb 
 
 
 
At puncture 
site11,13,14,17 
 
Hematoma 
 
Nerve 
irritation 
Arterial 
puncture 
 
Pain 
Infection 
Distant of 
puncture 
site11,13,14,16 
 
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.17-19 Mild citrate reactions are very common with apheresis procedures, while 
vasovagal reactions are substantially lower compared to whole blood donation.14,17 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 
Reactions13,14, 
17,20 
 
Paresthesia 
Nausea 
Vomiting 
Tetany 
Arrhythmia 
Cardiac arrest 
Lightheadedness 
Cramps 
Seizure 
Metallic taste 
Spasms 
Chills 
Vasovagal 
Reactionsa 14,17 
 
 
Presyncopeb 
Vomiting 
Convulsion 
LOC with 
trauma injury  
 
Weakness 
Hypotension 
Seizure 
Syncope 
Bradycardia 
Other Notable 
Events13,14,17,21 
 
 
 
 
 
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.  
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 

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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.22 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. 

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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 
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.  

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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, InterSol solution, and software will be provided 
by Terumo BCT for use in this study. The Trima Accel disposables and InterSol solution 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 fewer 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 that affects the 
primary or secondary endpoint 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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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. Alhumaidan H, Sweeney J. Current status of additive solutions for platelets. J Clin Apher 
2012;27(2):93-8. 
6. Holme S, Heaton WAL, Whitley P. Platelet Storage Lesions in Second Generation 
Containers: Correlation with in vivo Behavior with Storage up to 14 Days. Vox Sanguinis 
1990;59(1):12-8. 
7. Slichter SJ, Corson J, Jones MK, Christoffel T, Pellham E, Bailey SL, Bolgiano D. 
Exploratory studies of extended storage of apheresis platelets in a platelet additive 
solution (PAS). Blood 2014;123(2):271-80. 
8. American Association for Blood Banks. Donor Services Training Manual. September 
2012. 
9. Center for Biologics Evaluation and Research. Guidance for Industry and FDA Review 
Staff: Collection of Platelets by Automated Methods. December 2007. 
10. Center for Biologics Evaluation and Research. Guidance for Industry: Pre-Storage 
Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion. 
September 2012. 
11. Sorensen BS, Johnsen SP, Jorgensen J. Complications related to blood donation: a 
population-based study. Vox sanguinis. Feb 2008;94(2):132-137. 
12. 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. 
13. Danic B, Lefort C. Effets indésirables donneurs et leur prise en charge. Transfusion 
Clinique et Biologique. Dec 2010;17(5–6):301-305. 
14. 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. 
15. Deacon B, Abramowitz J. Fear of needles and vasovagal reactions among phlebotomy 
patients. Journal of anxiety disorders. 2006;20(7):946-960. 

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16. 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. 
17. McLeod BC, Price TH, Owen H, et al. Frequency of immediate adverse effects 
associated with apheresis donation. Transfusion. Oct 1998;38(10):938-943. 
18. 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. 
19. Shehata N, Kusano R, Hannach B, Hume H. Reaction rates in allogeneic donors. 
Transfusion medicine. Oct 2004;14(5):327-333. 
20. 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. 
21. Nakajima K. Donor complications and donor care. ISBT Science Series. 2009;4(n2):411-
417. 
22. 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 
Platelet Additive Solution 
Study Number: 
CTS-5059 
Version/Date: 
Version 4.0/22 NOV 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