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

• Safety:
• • Rate of major adverse cardiac events (MACE) at hospital discharge and 30 days post procedure.
• • Renal failure resulting in one of the following:
• o a new requirement for dialysis
• o increase of serum creatinine to greater than an absolute value of 220 umol/L and two times the baseline creatinine level, but does not require dialysis
• • Rate of Cardiac Troponin T elevation through hospital discharge
• • Individual rates of death, MI and stroke
• Efficacy:
• • Rate of supplemental RBC transfusions
• • Total units RBC or HBOC-201 administered
• • Change in renal function assessed by changes in serum creatinine levels from baseline through hospital discharge
• • Rate of intra-aortic balloon pump (IABP) support and total pump time
• • New onset of congestive heart failure (CHF) through hospital discharge
• • Procedural cross-clamp time
• • Total patient ventilation time
• • Time to hospital discharge
• • Cognitive impairment, defined as change in neurocognitive testing assessment from baseline to hospital discharge

The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.

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.

• Experimental: 1
  Intervention: Drug: HBOC-201 (hemoglobin glutamer-250 bovine)
• No Intervention: 2

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.