Evaluation of Trima Version 7.0 Platelets in PAS

Study Overview
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Brief Summary
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To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

Detailed Description
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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. This is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of platelets stored in platelet additive solution (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 participation will be up to 30 days and will consist of 1 to 2 visits. Screening may be done within 30 days before 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.

Official Title
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Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Trima Accel System with Version 7.0 Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older. 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. Has given written informed consent. Exclusion Criteria: Has previously donated an evaluable platelet product in this study (CTS 5059).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Platelet Product<br>Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. | Device: Trima Accel System with Version 7.0 Software<br>* Platelet Apheresis Procedure<br>|
| Experimental: Double Platelet Product<br>Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. | Device: Trima Accel System with Version 7.0 Software<br>* Platelet Apheresis Procedure<br>|
| Experimental: Triple Platelet Product<br>Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. | Device: Trima Accel System with Version 7.0 Software<br>* Platelet Apheresis Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level | The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit. | Within 48 hours of end of donation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Platelet Units Containing an Acceptable Platelet Yield | The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples. | Within 48 hours of end of donation |