NCT02754440

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

April 26, 2016

Results QC Date

April 9, 2018

Last Update Submit

April 9, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Platelet Units Containing an Acceptable Platelet Yield

    Within 48 hours of end of donation

Study Arms (3)

Single Platelet Product

EXPERIMENTAL

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

Double Platelet Product

EXPERIMENTAL

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

Triple Platelet Product

EXPERIMENTAL

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

Interventions

Trima Accel System with Version 7.0 SoftwareDEVICE

Platelet Apheresis Procedure

Double Platelet ProductSingle Platelet ProductTriple Platelet Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Has given written informed consent.

You may not qualify if:

  • Has previously donated an evaluable platelet product in this study (CTS 5059).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

San Diego Blood Bank

San Diego, California, 92102, United States

Location

Bonfils Blood Center

Denver, Colorado, 80230, United States

Location

Indiana Blood Center

Indianapolis, Indiana, 46208, United States

Location

Memorial Blood Centers

Minneapolis, Minnesota, 55114, United States

Location

Community Blood Center of Greater Kansas

Kansas City, Missouri, 64111-2390, United States

Location

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Results Point of Contact

Title
Heather Pidcoke, MD, PhD
Organization
Terumo BCT, Inc.
Heather.Pidcoke@terumobct.com
(303) 231-4805

Study Officials

  • Heather Pidcoke, MD, PhD

    Terumo BCT, Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 28, 2016

Study Start

April 20, 2016

Primary Completion

July 28, 2017

Study Completion

July 28, 2017

Last Updated

May 11, 2018

Results First Posted

May 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(7)