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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301535
Recruitment Status : Unknown
Verified May 2008 by Biopure Corporation.
Recruitment status was:  Recruiting
First Posted : March 13, 2006
Last Update Posted : May 16, 2008
Information provided by:
Biopure Corporation

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: HBOC-201 (hemoglobin glutamer-250 bovine) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
Study Start Date : February 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Chrysarobin

Arm Intervention/treatment
Experimental: 1 Drug: HBOC-201 (hemoglobin glutamer-250 bovine)
HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL

No Intervention: 2

Primary Outcome Measures :
  1. Rate of peak CK-MB elevation ≥ 5X upper limit of normal [ Time Frame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier) ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Duration of the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301535

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Contact: Tiana Gorham

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Thessaloniki Heart Institute - St. Luke's Hospital Recruiting
Thessaloniki, Greece, 552 36
Contact: Julia Tzelepi, MD   
Principal Investigator: Antonis Pitsis, MD         
South Africa
Milpark Hospital Recruiting
Johannesburg, South Africa
Contact: Ronel Snyman   
Principal Investigator: Martin Sussman, MD         
Sub-Investigator: Christopher A Hammond, MD         
United Kingdom
Oxford Heart Centre - John Radcliffe Hospital Recruiting
Headington, Oxfordshire, United Kingdom, OX3 9DU
Principal Investigator: Stephen Westaby, MD         
Sponsors and Collaborators
Biopure Corporation
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Study Director: A. Gerson Greenburg, MD, Ph.D Biopure Corporation
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Responsible Party: Biopure Identifier: NCT00301535    
Other Study ID Numbers: BIOEU003
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008
Keywords provided by Biopure Corporation:
Coronary Artery Bypass Graft
memory loss after cardiac surgery
side effects of bypass
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
HBOC 201
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Blood Substitutes