Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-20 @ 1:40 PM
Study NCT ID:
NCT02754492
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Trima Version 7.0 Platelets in 100% Plasma
Sponsor:
Terumo BCT
Organization:
Study Overview
Official Title:
Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in 100% Plasma
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: