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Inactivation of Whole Blood With Mirasol

NCT01907906 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-08-18

Study results available
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Summary

The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects

Conditions

  • Focus of Study: Radiolabel Recovery and Survival of RBCs

Interventions

DEVICE

Mirasol System for Whole Blood

LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Terumo BCTbio

    lead INDUSTRY

Principal Investigators

  • Raymond P Goodrich, PhD · TerumoBCT Biotechnologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT01907906 on ClinicalTrials.gov