Status:
UNKNOWN
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Lead Sponsor:
Biopure Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 preserva...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00301535
Start Date
February 1 2006
End Date
September 1 2008
Last Update
May 16 2008
Active Locations (3)
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1
Thessaloniki Heart Institute - St. Luke's Hospital
Thessaloniki, Greece, 552 36
2
Milpark Hospital
Johannesburg, South Africa
3
Oxford Heart Centre - John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom, OX3 9DU