Clinical trial NCT02754440: Evaluation of Trima Version 7.0 Platelets in PAS
Official title: Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Terumo BCT
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility 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).

Primary outcomes:
measure: Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level
timeFrame: Within 48 hours of end of donation
Secondary outcomes:
measure: Number of Participants With Platelet Units Containing an Acceptable Platelet Yield
timeFrame: Within 48 hours of end of donation
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Blood Bank
state: California
city: Denver
country: United States
facility: Bonfils Blood Center
state: Colorado
city: Indianapolis
country: United States
facility: Indiana Blood Center
state: Indiana
city: Minneapolis
country: United States
facility: Memorial Blood Centers
state: Minnesota
city: Kansas City
country: United States
facility: Community Blood Center of Greater Kansas
state: Missouri
city: Cincinnati
country: United States
facility: Hoxworth Blood Center
state: Ohio
city: Milwaukee
country: United States
facility: Blood Center of Wisconsin
state: Wisconsin
Study officials:
affiliation: Terumo BCT, Inc
name: Heather Pidcoke, MD, PhD
role: STUDY_DIRECTOR
References: