A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
NCT ID: NCT00301535
Last Updated: 2008-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2006-02-28
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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
2
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Biopure Corporation
INDUSTRY
Responsible Party
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Biopure
Principal Investigators
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A. Gerson Greenburg, MD, Ph.D
Role: STUDY_DIRECTOR
Biopure Corporation
Locations
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Thessaloniki Heart Institute - St. Luke's Hospital
Thessaloniki, , Greece
Milpark Hospital
Johannesburg, , South Africa
Oxford Heart Centre - John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Julia Tzelepi, MD
Role: primary
Ronel Snyman
Role: primary
Other Identifiers
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BIOEU003
Identifier Type: -
Identifier Source: org_study_id