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In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

NCT03097289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-12-19

Study results available
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Summary

The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

Trima Accel system

A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 5 day storage. The entire procedure is painless and should take 90 to 120 minutes.

Sponsors & Collaborators

  • Terumo BCT

    lead INDUSTRY

Principal Investigators

  • Jose Cancelas, MD, PhD · Hoxworth Blood Center

  • Mehraboon S Irani, MD · Versiti

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2017-11-24
Completion
2017-11-24
FDA Device
Yes

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 NCT03097289 on ClinicalTrials.gov