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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Biopure Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biopure Corporation
ClinicalTrials.gov Identifier:
NCT00301535
First received: March 9, 2006
Last updated: May 15, 2008
Last verified: May 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)

Resource links provided by NLM:


Further study details as provided by Biopure Corporation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301535

Contacts
Contact: Tiana Gorham tgorham@biopure.com

Locations
Greece
Thessaloniki Heart Institute - St. Luke's Hospital Recruiting
Thessaloniki, Greece, 552 36
Contact: Julia Tzelepi, MD       ktzelepipal@yahoo.gr   
Principal Investigator: Antonis Pitsis, MD         
South Africa
Milpark Hospital Recruiting
Johannesburg, South Africa
Contact: Ronel Snyman       research.jhb@mweb.co.za   
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
Investigators
Study Director: A. Gerson Greenburg, MD, Ph.D Biopure Corporation
  More Information

No publications provided

Responsible Party: Biopure
ClinicalTrials.gov Identifier: NCT00301535     History of Changes
Other Study ID Numbers: BIOEU003
Study First Received: March 9, 2006
Last Updated: May 15, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: National Organization of Medicines
South Africa: Medicines Control Council

Keywords provided by Biopure Corporation:
Coronary Artery Bypass Graft
memory loss after cardiac surgery
side effects of bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
HBOC 201
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014