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Sponsored by: |
Biopure Corporation |
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Information provided by: | Biopure Corporation |
ClinicalTrials.gov Identifier: | NCT00301535 |
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Drug: HBOC-201 (hemoglobin glutamer-250 bovine) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study) |
Estimated Enrollment: | 60 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: HBOC-201 (hemoglobin glutamer-250 bovine)
HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL
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2: No Intervention |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tiana Gorham | tgorham@biopure.com |
Greece | |
Thessaloniki Heart Institute - St. Luke's Hospital | Recruiting |
Thessaloniki, Greece, 552 36 | |
Contact: Julia Tzelepi, MD ktzelepipal@yahoo.gr | |
Principal Investigator: Antonis Pitsis, MD | |
South Africa | |
Milpark Hospital | Recruiting |
Johannesburg, South Africa | |
Contact: Ronel Snyman research.jhb@mweb.co.za | |
Principal Investigator: Martin Sussman, MD | |
Sub-Investigator: Christopher A Hammond, MD | |
United Kingdom, Oxfordshire | |
Oxford Heart Centre - John Radcliffe Hospital | Recruiting |
Headington, Oxfordshire, United Kingdom, OX3 9DU | |
Principal Investigator: Stephen Westaby, MD |
Study Director: | A. Gerson Greenburg, MD, Ph.D | Biopure Corporation |
Responsible Party: | Biopure ( Biopure ) |
Study ID Numbers: | BIOEU003 |
Study First Received: | March 9, 2006 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00301535 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Greece: National Organization of Medicines; South Africa: Medicines Control Council |
Coronary Artery Bypass Graft memory loss after cardiac surgery side effects of bypass |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
HBOC 201 Arteriosclerosis Ischemia Coronary Artery Disease Amnesia |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases HBOC 201 Arteriosclerosis |
Pharmacologic Actions Coronary Disease Therapeutic Uses Blood Substitutes Cardiovascular Diseases Coronary Artery Disease |