Study Results
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View full resultsBasic Information
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COMPLETED
NA
365 participants
INTERVENTIONAL
2016-04-20
2017-07-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
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.
Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
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.
Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
Interventions
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Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
Eligibility Criteria
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Inclusion Criteria
* Has given written informed consent.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Terumo BCT
INDUSTRY
Responsible Party
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Principal Investigators
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Heather Pidcoke, MD, PhD
Role: STUDY_DIRECTOR
Terumo BCT, Inc
Locations
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San Diego Blood Bank
San Diego, California, United States
Bonfils Blood Center
Denver, Colorado, United States
Indiana Blood Center
Indianapolis, Indiana, United States
Memorial Blood Centers
Minneapolis, Minnesota, United States
Community Blood Center of Greater Kansas
Kansas City, Missouri, United States
Hoxworth Blood Center
Cincinnati, Ohio, United States
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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CTS-5059
Identifier Type: -
Identifier Source: org_study_id
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