Trima Accel® System Post Count Algorithm Study

Terumo BCT131 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

131

Conditions

Healthy Volunteers

Interventions

Trima Accel SystemDEVICE

Platelet Apheresis Procedure

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

San Diego Blood Bank

San Diego, California, United States

Bonfils Blood Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Donor Postprocedure Platelet Count Following Donation of Single Platelet Product

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.

Time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

Donor Postprocedure Platelet Count Following Donation of Double Platelet Product

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.

Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

Data from ClinicalTrials.gov

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