Evaluation of Trima Version 7.0 Platelets in PAS
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/12/2018 |
| Start Date: | April 20, 2016 |
| End Date: | July 28, 2017 |
Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution
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).
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).
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.
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.
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).
We found this trial at
7
sites
Cincinnati, Ohio 45267
Principal Investigator: Jose Cancelas, MD, PhD
Phone: 513-558-1525
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Indianapolis, Indiana 46208
Principal Investigator: Dan Waxman, MD
Phone: 317-916-5049
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Kansas City, Missouri 64111
Principal Investigator: Beth Shaz, MD
Phone: 816-968-4069
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Milwaukee, Wisconsin 53233
Principal Investigator: Mehraboon Irani, MD
Phone: 414-937-6295
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Minneapolis, Minnesota 55114
Principal Investigator: Jed Gorlin, MD
Phone: 651-332-7222
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San Diego, California 92103
Principal Investigator: Diane Eklund, MD
Phone: 619-400-8150
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