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Evaluation of Trima Version 7.0 Platelets in PAS

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ClinicalTrials.gov Identifier: NCT02754440
Recruitment Status : Completed
First Posted : April 28, 2016
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Terumo BCT

Study Description
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Brief Summary:
To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: Trima Accel System with Version 7.0 Software Not Applicable

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 platelet additive solution (PAS) collected on the Trima Accel system Version 7.0 software enhancement. Up to 450 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution
Actual Study Start Date : April 20, 2016
Actual Primary Completion Date : July 28, 2017
Actual Study Completion Date : July 28, 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level [ Time Frame: Within 48 hours of end of donation ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Platelet Units Containing an Acceptable Platelet Yield [ Time Frame: Within 48 hours of end of donation ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA guidance and 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 5059).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754440


Locations
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United States, California
San Diego Blood Bank
San Diego, California, United States, 92102
United States, Colorado
Bonfils Blood Center
Denver, Colorado, United States, 80230
United States, Indiana
Indiana Blood Center
Indianapolis, Indiana, United States, 46208
United States, Minnesota
Memorial Blood Centers
Minneapolis, Minnesota, United States, 55114
United States, Missouri
Community Blood Center of Greater Kansas
Kansas City, Missouri, United States, 64111-2390
United States, Ohio
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
United States, Wisconsin
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Terumo BCT
Investigators
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Study Director: Heather Pidcoke, MD, PhD Terumo BCT, Inc
  Study Documents (Full-Text)

Documents provided by Terumo BCT:
Study Protocol  [PDF] November 22, 2016
Informed Consent Form  [PDF] November 22, 2016
Statistical Analysis Plan  [PDF] May 17, 2017

More Information
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Responsible Party: Terumo BCT
ClinicalTrials.gov Identifier: NCT02754440    
Other Study ID Numbers: CTS-5059
First Posted: April 28, 2016    Key Record Dates
Results First Posted: May 11, 2018
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No