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

Biopure

Status and phase

Unknown

Phase 2

Conditions

Coronary Artery Disease

Treatments

Drug: HBOC-201 (hemoglobin glutamer-250 bovine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00301535

BIOEU003

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.