NCT01907906

Inactivation of Whole Blood With Mirasol

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Terumo BCTbio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1

Conditions

• Focus of Study: Radiolabel Recovery and Survival of RBCs

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-07-25
• Last updated: 2015-08-18
• Results posted: 2015-07-27

Locations

2 sites across 1 country: United States