NCT02684630

Trima Accel® System Post Count Algorithm Study

A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Terumo BCT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Trima Accel System	Platelet Apheresis Procedure

Timeline

• Start date: 2016-01-28
• Primary completion: 2016-05-28
• Completion: 2016-05-28
• First posted: 2016-02-18
• Last updated: 2017-07-12
• Results posted: 2017-06-08

Locations

2 sites across 1 country: United States