Trima Accel® System Post Count Algorithm Study

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT02684630
• Lead Sponsor: Terumo BCT

Brief 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.

Study Timeline

• Study First Submitted: 2015-11-03
• Study Start: 2016-01-28
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-18
• Primary Completion: 2016-05-28
• Study Completion: 2016-05-28
• Results First Submitted: 2017-04-19
• Results First Submitted QC: 2017-05-08
• Status Verified: 2017-06
• Results First Posted: 2017-06-08
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

• Age ≥ 18 years.
• Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
• Appears to have adequate venous access to obtain a postprocedure platelet count.
• Has given written informed consent.

Exclusion Criteria

• Has undergone a splenectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Donor Postprocedure Platelet Count Following Donation of Single Platelet Product	The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis	The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was \< 100,000 platelets/μL.
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product	The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis	The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.

Trial Locations

Locations (2)

San Diego Blood Bank; 🇺🇸 San Diego, California, United States

Bonfils Blood Center; 🇺🇸 Denver, Colorado, United States