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

• Status: Unknown status
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biopure Corporation
• Treatments: HBOC 201

Criteria

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.