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Evaluation of Trima Version 7.0 Platelets in 100% Plasma

NCT02754492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2018-03-29

Study results available
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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).

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Trima Accel System with Version 7.0 Software

Platelet Apheresis Procedure

Sponsors & Collaborators

  • Terumo BCT

    lead INDUSTRY

Principal Investigators

  • Heather Pidcoke, MD, PhD · Terumo BCT, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-02-15
Completion
2017-02-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02754492 on ClinicalTrials.gov