Evaluation of Trima Version 7.0 Platelets in 100% Plasma

Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in 100% Plasma

To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in 100% plasma meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Trima Accel System with Version 7.0 Software

Detailed Description

The study is designed to evaluate changes to the Trima Accel software to ensure the modified software meets the FDA acceptance criteria for leukoreduction and platelet yield. The operating range for the system flow rates, anticoagulant ratios, storage conditions, and centrifugal forces are the same as the currently cleared Trima Accel system. There are no changes to the environment or storage conditions for platelets, therefore, no in vitro or in vivo platelet quality data will be collected.

This is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of platelets stored in 100% plasma collected on the Trima Accel system Version 7.0 software enhancement. Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 single, 93 double and 93 triple platelet product evaluable data points. Evaluable is defined as a completed platelet product that does not meet any of the protocol analysis exclusion criteria.

Plateletpheresis will be per site standard practice and per applicable FDA guidelines such as the FDA Collection of Platelets by Automated Methods, December 2007 Guidance for Industry and Pre-storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion, September 2012.

Study participation will be up to 30 days and will consist of 1 to 2 visits. Screening may be done within 30 days before the apheresis procedure or combined as a single visit, which includes screening and the apheresis procedure all in 1 day.

The entire study should be completed in approximately 16 months.

• Study Type: Interventional
• Enrollment (Actual): 334
• 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
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • Indiana Blood Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55114
      • Memorial Blood Centers
  • Missouri
    • Kansas City, Missouri, United States, 64111-2390
      • Community Blood Center of Greater Kansas
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Hoxworth Blood Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Blood Center of Wisconsin

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 or older.
• Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with plasma collection on the Trima Accel system. These criteria are based on FDA guidance and the American Association of Blood Banks (AABB) standards. Note: subjects who are deferred from volunteer community donations because of travel restrictions, piercings, or tattoos may participate in the study, as products are not transfused.
• Has given written informed consent.

Exclusion Criteria:

• Has previously donated an evaluable platelet product in this study (CTS 5060).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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 will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.	Device: Trima Accel System with Version 7.0 Software; Platelet Apheresis Procedure
EXPERIMENTAL: Double Platelet Product; Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections.	Device: Trima Accel System with Version 7.0 Software; Platelet Apheresis Procedure
EXPERIMENTAL: Triple Platelet Product; Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections	Device: Trima Accel System with Version 7.0 Software; Platelet Apheresis Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level	The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.	Within 48 hours of end of donation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Platelet Units Containing an Acceptable Platelet Yield	The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.	Within 48 hours of end of donation

Collaborators and Investigators

• Sponsor: Terumo BCT

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): February 15, 2017
• Study Completion (ACTUAL): February 15, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (ESTIMATE): April 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CTS-5060

Plan for Individual participant data (IPD)

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