Healthy Volunteers Clinical Trial
Official title:
A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
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.
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:
1. a single platelet product is collected
2. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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