CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Mirasol treatment of whole blooddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02330081
NCT02330081N/ACompleted

Mirasol System for Whole Blood: Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood in Healthy Volunteers

Terumo BCTbio·interventional·Posted Jan 1, 2015·Updated Jun 12, 2019

In Brief

A clinical study evaluating Mirasol treatment of whole blood for Blood Safety. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Safety
CountriesNorway

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 1, 2015
Enrollment StartApr 1, 2015
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.5 years ago

Interventions

Mirasol treatment of whole blooddevice

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.