Healthy Volunteers Clinical Trial
Official title:
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).
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.
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