- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754440
Evaluation of Trima Version 7.0 Platelets in PAS
Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92102
- San Diego Blood Bank
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Colorado
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Denver, Colorado, United States, 80230
- Bonfils Blood Center
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Indiana
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Indianapolis, Indiana, United States, 46208
- Indiana Blood Center
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Minnesota
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Minneapolis, Minnesota, United States, 55114
- Memorial Blood Centers
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Missouri
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Kansas City, Missouri, United States, 64111-2390
- Community Blood Center of Greater Kansas
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Ohio
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Cincinnati, Ohio, United States, 45267
- Hoxworth Blood Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53233
- Blood Center of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Platelet Product
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.
|
Platelet Apheresis Procedure
|
Experimental: Double Platelet Product
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.
|
Platelet Apheresis Procedure
|
Experimental: Triple Platelet Product
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.
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Platelet Apheresis Procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level
Time Frame: Within 48 hours of end of donation
|
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
Time Frame: Within 48 hours of end of donation
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CTS-5059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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