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

March 9, 2006
May 15, 2008
February 2006
July 2008   (final data collection date for primary outcome measure)
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 ]
Rate of peak CK-MB elevation ≥ 5 times the upper limit of normal
Complete list of historical versions of study NCT00301535 on ClinicalTrials.gov Archive Site
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 ]
  • Safety:
  • • Rate of major adverse cardiac events (MACE) at hospital discharge and 30 days post procedure.
  • • Renal failure resulting in one of the following:
  • o a new requirement for dialysis
  • o increase of serum creatinine to greater than an absolute value of 220 umol/L and two times the baseline creatinine level, but does not require dialysis
  • • Rate of Cardiac Troponin T elevation through hospital discharge
  • • Individual rates of death, MI and stroke
  • Efficacy:
  • • Rate of supplemental RBC transfusions
  • • Total units RBC or HBOC-201 administered
  • • Change in renal function assessed by changes in serum creatinine levels from baseline through hospital discharge
  • • Rate of intra-aortic balloon pump (IABP) support and total pump time
  • • New onset of congestive heart failure (CHF) through hospital discharge
  • • Procedural cross-clamp time
  • • Total patient ventilation time
  • • Time to hospital discharge
  • • Cognitive impairment, defined as change in neurocognitive testing assessment from baseline to hospital discharge
Not Provided
Not Provided
 
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
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
  • Experimental: 1
    Intervention: Drug: HBOC-201 (hemoglobin glutamer-250 bovine)
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Tiana Gorham tgorham@biopure.com
South Africa,   United Kingdom,   Greece
 
NCT00301535
BIOEU003
Yes
Biopure
Biopure Corporation
Not Provided
Study Director: A. Gerson Greenburg, MD, Ph.D Biopure Corporation
Biopure Corporation
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP