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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion |
|
| 2 | Other | Dry occlusion followed by occlusion with pre-oxygenated HBOC-201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure) | Drug | Pre-oxygenated HBOC-201 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study the change in left ventricular relaxation indices and pressure-half time and the change in the sum of ST segment deviations compared to baseline. | Duration of the study |
| Measure | Description | Time Frame |
|---|---|---|
| LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints | Duration of the study |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria at the end of PCI (before randomization)
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| Name | Affiliation | Role |
|---|---|---|
| A. Gerson Greenburg, MD, PhD | Biopure Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxcentre - Erasmus MC | Rotterdam | Netherlands |
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| ID | Term |
|---|---|
| D054059 | Coronary Occlusion |
| D054058 | Acute Coronary Syndrome |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C096798 | HBOC 201 |
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