Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479895
Status:
COMPLETED
Last Update Posted:
2008-05-30
First Post:
2007-05-25
Brief Title:
Hemoglobin Based Oxygen Therapeutics in Elective Percutaneous Coronary Revascularization
Sponsor:
Biopure Corporation
Organization:
Biopure Corporation
Study Overview
Official Title:
Phase II Open-Label Study in the Catheterization Laboratory Setting to Challenge the Concept That HBOC-201 Administration Might Improve Myocardial Oxygenation and Myocardial Function at the Moment of Brief Coronary Occlusion
Status:
COMPLETED
Status Verified Date:
2008-05
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:
None
Brief Summary:
The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier HBOC-201 Hemopure HBOC-201 initially developed as an alternative to red blood cells for surgical patients has the ability to restore tissue oxygenation in persistently ischemic tissue The development of this new class of compounds referred to as oxygen therapeutics provides an opportunity to test the safety and efficacy of a new approach to management of myocardial ischemia
Detailed Description:
Because of their ability to perfuse and deliver oxygen hemoglobin-based oxygen carriers HBOC may be considered in the treatment of several ischemic conditions such as acute coronary syndromes ACS Elective percutaneous intervention PCI induces transient myocardial ischemia due to reduction of coronary flow during balloon inflation in the coronary artery thus simulating in a control setting the occurrence of an ACS
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?:
None