Blood Safety Clinical Trial
Official title:
Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers
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.
The study will be a prospective, single-center, single-arm, intra-subject controlled,
open-label design.
Subjects will donate one unit of fresh whole blood. This unit will be treated with the
Mirasol PRT System for whole blood and then stored for 24 hours ± 1 hour at 22 ± 2°C. At the
end of storage, platelet concentrates will be separated from the unit according to the
Biomedical Excellence for Safer Transfusion (BEST) procedures. An aliquot will be removed
from the platelet concentrates for testing and for radiolabeling and reinfusion. The
platelets in Mirasol-treated whole blood will be tested for key in vitro parameters directly
after treatment (Day 0) and at the end of storage (Day 1). Sterility testing will also be
conducted on the stored units.
An aliquot of the platelet concentrate separated from each unit of stored Mirasol-treated
whole blood will be radiolabeled with either 111Indium Oxine or 51Chromium, and autologously
infused. An intra-subject control will be utilized as per the BEST guidelines for platelet
radiolabeling procedures. On the day of infusion, the subject will donate a fresh sample of
whole blood. Platelets will be separated from this fresh sample and labeled with the
radio-isotope that was not used to label the subject's Mirasol-treated platelet sample. The
two radiolabeled platelet aliquots (Mirasol-treated and fresh control) will be infused
simultaneously, and the recovery and survival of the two types of platelets will be measured
according to standard institutional practice.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02513966 -
Decreased Consumption of Blood Components During Cardiac Surgery Procedures: Causes and Effects.
|