A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
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ClinicalTrials.gov Identifier: NCT00301535 |
Recruitment Status : Unknown
Verified May 2008 by Biopure Corporation.
Recruitment status was: Recruiting
First Posted : March 13, 2006
Last Update Posted : May 16, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Drug: HBOC-201 (hemoglobin glutamer-250 bovine) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study) |
Study Start Date : | February 2006 |
Estimated Primary Completion Date : | July 2008 |
Estimated Study Completion Date : | September 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
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 |
No Intervention: 2 |
- Rate of peak CK-MB elevation ≥ 5X upper limit of normal [ Time Frame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier) ]
- MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF [ Time Frame: Duration of the study ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is between the ages of 18 and 80.
- Subject is an acceptable candidate for CABG.
- Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.
- Subject signs informed consent
- Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.
Exclusion Criteria:
- Pre-operative myocardial infarction, defined as CK-MB level > 2 times upper limit of normal 24 hours prior to CABG surgery.
- Renal failure defined as serum creatinine greater 220 µmol/L
- Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).
- Active infection.
- History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
- Transient Ischemic attack within last 6 months.
- Subject has a history of coagulopathy.
- Subject is pregnant or currently breastfeeding.
- History of allergy to beef products.
- Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.L/min/m2 despite the use of vasopressors.
- Underlying medical conditions that would limit subject's life expectancy to less than 12 months.
- Severe pulmonary disease [based upon clinical diagnosis or pulmonary function tests (FEV <1 liter), if available] that may interfere with weaning subject from ventilator.
- History of acute central nervous disorder (e.g., seizure or traumatic injury).
- Severe hypertension (≥ 160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.
- Severe liver dysfunction as defined by total bilirubin ≥ 51 µmol/L or 2 times the site normal limit of AST or ALT activity.
- Subject has systemic mastocytosis.
- Subject has any condition that predisposes the subject to systemic mast cell degranulation or hypersensitivity reactions or a history of severe allergic reactions to drugs or environmental allergens.
- Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301535
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 | |
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 |
ClinicalTrials.gov Identifier: | NCT00301535 |
Other Study ID Numbers: |
BIOEU003 |
First Posted: | March 13, 2006 Key Record Dates |
Last Update Posted: | May 16, 2008 |
Last Verified: | May 2008 |
Coronary Artery Bypass Graft memory loss after cardiac surgery side effects of bypass |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases HBOC 201 Blood Substitutes |