Ignite Creation Date:
2025-12-18 @ 5:45 AM
Ignite Modification Date:
2025-12-23 @ 10:40 PM
Study NCT ID:
NCT00742001
Status:
None
Last Update Posted:
2019-08-28 00:00:00
First Post:
2008-08-25 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Sponsor:
None
Organization:
Study Overview
Official Title:
IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation
Status:
None
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
An endpoint difference between 3 energies was not observed at interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: