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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Trima Accel System

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 Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92102
      • San Diego Blood Bank
  • Colorado
    • Denver, Colorado, United States, 80230
      • Bonfils Blood Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Platelet Product; Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).	Device: Trima Accel System; Platelet Apheresis Procedure
EXPERIMENTAL: Double Platelet Product; Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).	Device: Trima Accel System; Platelet Apheresis Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

Collaborators and Investigators

• Sponsor: Terumo BCT

Study record dates

Study Major Dates

• Study Start: January 28, 2016
• Primary Completion (ACTUAL): May 28, 2016
• Study Completion (ACTUAL): May 28, 2016

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (ESTIMATE): February 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CTS-5054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO