Evaluation of Trima Version 7.0 Platelets in PAS

Completed · Not applicable

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT02754440

Run by

Terumo BCT

People needed

365

Starts

2016-04-20

Expected to finish

2017-07-28

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Has previously donated an evaluable platelet product in this study (CTS 5059).

Where it is running

• San Diego Blood Bank — San Diego, California, United States
• Bonfils Blood Center — Denver, Colorado, United States
• Indiana Blood Center — Indianapolis, Indiana, United States
• Memorial Blood Centers — Minneapolis, Minnesota, United States
• Community Blood Center of Greater Kansas — Kansas City, Missouri, United States
• Hoxworth Blood Center — Cincinnati, Ohio, United States
• Blood Center of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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