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

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

Detailed Description
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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.

Official Title
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Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: HBOC-201 (hemoglobin glutamer-250 bovine)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: HBOC-201 (hemoglobin glutamer-250 bovine)<br>* HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Graft, memory loss after cardiac surgery, side effects of bypass