Trima Accel® System Post Count Algorithm Study

Study Overview
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Brief Summary
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The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.

Detailed Description
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This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software. Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which: a single platelet product is collected a double platelet product is collected, with or without other components. Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant. Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Official Title
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A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Trima Accel System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines. Appears to have adequate venous access to obtain a postprocedure platelet count. Has given written informed consent. Exclusion Criteria: Has undergone a splenectomy.

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: Basic Science
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, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). | Device: Trima Accel System<br>* Platelet Apheresis Procedure<br>|
| Experimental: Double Platelet Product<br>Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). | Device: Trima Accel System<br>* Platelet Apheresis Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL. | The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis | 
| Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. | The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis |