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

May 15, 2008 updated by: Biopure Corporation

Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Thessaloniki, Greece, 552 36
        • Recruiting
        • Thessaloniki Heart Institute - St. Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Antonis Pitsis, MD
  • South Africa
      • Johannesburg, South Africa
        • Recruiting
        • Milpark Hospital
        • Contact:
        • Principal Investigator:
          • Martin Sussman, MD
        • Sub-Investigator:
          • Christopher A Hammond, MD
  • United Kingdom
    • Oxfordshire
      • Headington, Oxfordshire, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford Heart Centre - John Radcliffe Hospital
        • Principal Investigator:
          • Stephen Westaby, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopure Corporation

Investigators

  • Study Director: A. Gerson Greenburg, MD, Ph.D, Biopure Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Anticipated)

July 1, 2008

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 10, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOEU003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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