Trima Accel® System Post Count Algorithm Study

NCT02684630 | Completed Results

• 1 other identifier: CTS-5054
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of \>100,000/µL.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Donor Postprocedure Platelet Count Following Donation of Single Platelet Product

  The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was \< 100,000 platelets/μL.

  The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

• Donor Postprocedure Platelet Count Following Donation of Double Platelet Product

  The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.

  The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

Study Arms (2)

Single Platelet Product

EXPERIMENTAL

Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).

Device: Trima Accel System

Double Platelet Product

EXPERIMENTAL

Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).

Device: Trima Accel System

Interventions

Trima Accel System DEVICE

Platelet Apheresis Procedure

Double Platelet Product; Single Platelet Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.
• Appears to have adequate venous access to obtain a postprocedure platelet count.
• Has given written informed consent.

You may not qualify if:

• Has undergone a splenectomy.

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (2)

San Diego Blood Bank

San Diego, California, 92102, United States

Location

Bonfils Blood Center

Denver, Colorado, 80230, 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
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: February 18, 2016
• Study Start: January 28, 2016
• Primary Completion: May 28, 2016
• Study Completion: May 28, 2016
• Last Updated: July 12, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)