Who is sponsoring IMPROVEII?

IMPROVEII is sponsored by Terumo BCTbio.

What condition does IMPROVEII study?

IMPROVEII studies Focus of Study: Radiolabel Recovery and Survival of RBCs.

What drugs are being tested in IMPROVEII?

Interventions: Mirasol System for Whole Blood.

What is the status of IMPROVEII?

IMPROVEII is currently COMPLETED.

Last reviewed 2015-07-28 · How we verify

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

NCT01907906 Phase 1 COMPLETED Results posted

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

Details

Lead sponsor	Terumo BCTbio
Phase	Phase 1
Status	COMPLETED
Enrolment	29
Start date	2013-06
Completion	2014-05

Conditions

Focus of Study: Radiolabel Recovery and Survival of RBCs

Interventions

Mirasol System for Whole Blood

Primary outcomes

Red Blood Cell (RBC) 24-Hour Recovery — 24 hours
To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.

Countries

United States