Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT00301535
Status:
UNKNOWN
Last Update Posted:
2008-05-16
First Post:
2006-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Sponsor:
Biopure Corporation
Organization:
Study Overview
Official Title:
Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Detailed Description:
The primary objective is to determine the safety and feasibility of administering Hemopure® (HBOC-201) to reduce myocardial necrosis, as measured by CK-MB enzyme elevation, and enhance tissue preservation during cardiopulmonary bypass.
Study Oversight
Has Oversight DMC:
True
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?: