A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Phase 2
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: HBOC-201 (hemoglobin glutamer-250 bovine)
- Registration Number
- NCT00301535
- Lead Sponsor
- Biopure Corporation
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 HBOC-201 (hemoglobin glutamer-250 bovine) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (3)
Oxford Heart Centre - John Radcliffe Hospital
🇬🇧Headington, Oxfordshire, United Kingdom
Thessaloniki Heart Institute - St. Luke's Hospital
🇬🇷Thessaloniki, Greece
Milpark Hospital
🇿🇦Johannesburg, South Africa