Clinical trial NCT00301535: A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Official title: Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Bypass Graft
memory loss after cardiac surgery
side effects of bypass
Lead sponsor: Biopure Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Rate of peak CK-MB elevation ≥ 5X upper limit of normal
timeFrame: Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)
Secondary outcomes:
measure: 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
timeFrame: Duration of the study
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Thessaloniki Heart Institute - St. Luke's Hospital
city: Johannesburg
country: South Africa
facility: Milpark Hospital
city: Headington
country: United Kingdom
facility: Oxford Heart Centre - John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Biopure Corporation
name: A. Gerson Greenburg, MD, Ph.D
role: STUDY_DIRECTOR
References: