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Sponsored by: |
Biopure Corporation |
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Information provided by: | Biopure Corporation |
ClinicalTrials.gov Identifier: | NCT00479895 |
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.
Condition | Intervention | Phase |
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Coronary Occlusion Acute Coronary Syndrome |
Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 5 |
Study Start Date: | April 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion
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Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201
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2
Dry occlusion followed by occlusion with pre-oxygenated HBOC-201
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Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)
Pre-oxygenated HBOC-201
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria at the end of PCI (before randomization)
Study ID Numbers: | COR-0002 |
Study First Received: | May 25, 2007 |
Last Updated: | May 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00479895 History of Changes |
Health Authority: | Netherlands: Medical Ethics Review Committee of the Erasmus Medical Center, Rotterdam |
Percutaneous Coronary Intervention Myocardial Ischemia Balloon Occlusion Catheter Lab |
Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Acute Coronary Syndrome |
Vascular Diseases HBOC 201 Ischemia Coronary Artery Disease |
Disease Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases HBOC 201 Pharmacologic Actions Coronary Occlusion |
Coronary Disease Pathologic Processes Therapeutic Uses Syndrome Acute Coronary Syndrome Blood Substitutes Cardiovascular Diseases |