Coronary Artery Disease
Conditions
Keywords
Coronary Artery Bypass Graft, memory loss after cardiac surgery, side effects of bypass
Brief summary
The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.
Detailed description
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.
Interventions
DRUGHBOC-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
Sponsors
Biopure Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of peak CK-MB elevation ≥ 5X upper limit of normal | Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier) |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Duration of the study |
Countries
Greece, South Africa, United Kingdom
Contacts
Primary ContactTiana Gorham
Outcome results
None listed