Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 8:30 AM
Study NCT ID:
NCT01907906
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2013-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inactivation of Whole Blood With Mirasol
Sponsor:
Terumo BCTbio
Organization:
Study Overview
Official Title:
Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVEII
Brief 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
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ERMS#12308001 | OTHER_GRANT | Department of Defense | View |