Evaluation of Trima Version 7.0 Platelets in PAS

Healthy Volunteers Clinical Trial

Official title:

Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754440
• Other study ID #: CTS-5059
• Status: Completed
• Phase: N/A
• Start date: April 20, 2016
• Est. completion date: July 28, 2017

Study information

• Verified date: April 2018
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure

Locations

Country	Name	City	State
United States	Hoxworth Blood Center	Cincinnati	Ohio
United States	Bonfils Blood Center	Denver	Colorado
United States	Indiana Blood Center	Indianapolis	Indiana
United States	Community Blood Center of Greater Kansas	Kansas City	Missouri
United States	Blood Center of Wisconsin	Milwaukee	Wisconsin
United States	Memorial Blood Centers	Minneapolis	Minnesota
United States	San Diego Blood Bank	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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