A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery

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.