Clinical Trials Directory

Trials / Terminated

TerminatedNCT00742001

Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Terumo BCTbio · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Detailed description

Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Conditions

Interventions

TypeNameDescription
BIOLOGICALMirasol System for Whole Blood.Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Timeline

Start date
2008-09-10
Primary completion
2008-11-20
Completion
2008-12-16
First posted
2008-08-27
Last updated
2019-08-28
Results posted
2019-08-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00742001. Inclusion in this directory is not an endorsement.