CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
Mirasol System for 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/NCT01907906
NCT01907906Phase 1Completed
CompareCT.gov

Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers

Terumo BCTbio·interventional·Posted Jul 25, 2013·Updated Aug 18, 2015

In Brief

A Phase 1 clinical trial evaluating Mirasol System for Whole Blood for Focus of Study: Radiolabel Recovery and Survival of RBCs. Completed, enrolled 29 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocus of Study: Radiolabel Recovery and Survival of RBCs
CountriesUnited States
CollaboratorsU.S. Army Medical Research and Development Command

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 25, 2013
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.9 years ago

Interventions

Mirasol System for Whole Blooddevice

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.