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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00301535
• Other study ID #: BIOEU003
• Status: Recruiting
• Phase: Phase 2
• First received: March 9, 2006
• Last updated: May 15, 2008
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: May 2008
• Source: Biopure Corporation
• Contact: Tiana Gorham
• Email: tgorham[@]biopure.com
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGreece: National Organization of MedicinesSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Greece	Thessaloniki Heart Institute - St. Luke's Hospital	Thessaloniki
South Africa	Milpark Hospital	Johannesburg
United Kingdom	Oxford Heart Centre - John Radcliffe Hospital	Headington	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Biopure Corporation

Countries where clinical trial is conducted

Greece,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of peak CK-MB elevation = 5X upper limit of normal		Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)	No
Secondary	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		Duration of the study	Yes