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Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood

NCT02330081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-06-12

Study results available
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Summary

A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then stored for 24h. At the end of storage, platelet concentrates will be separated from the unit, tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets will be separated from this fresh sample and labeled with another radio-isotope. Then, the two radiolabeled platelet aliquots will be infused simultaneously and the recovery and survival of the two types of platelets will be measured.

Conditions

  • Blood Safety

Interventions

DEVICE

Mirasol treatment of whole blood

Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Terumo BCTbio

    lead INDUSTRY

Principal Investigators

  • Ray Goodrich, PhD · Terumo BCT VP Science, Clinical and Laboratory

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Norway

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 NCT02330081 on ClinicalTrials.gov