EUCTR2005-003639-30-GBActive, not recruitingPhase 1
Enhancement of Tissue Preservation During Cardiopulmonary Bypasswith HemoPure®
Biopure Corporation0 sites60 target enrollmentStarted: September 26, 2005Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Candidates for this study must meet ALL of the following criteria:
- •Subject is between the ages of 18 and 85.
- •Subject is an acceptable candidate for CABG.
- •Subject is scheduled for CABG (with or 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 visits at time of subject screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Candidates will be excluded from this study if ANY of the following criteria are present:
- •Pre-operative myocardial infarction, defined as CK level > 2 times upper limit of site normal 24 hours prior to CABG surgery.
- •Renal failure defined as serum creatinine greater than 220 umol/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.mL/min/m2 despite the use of vassopressors.
- •Underlying medical conditions that would limit subject’s life expectancy to less than 12 months.
- •Severe pulmonary impairment (e.g., emphysema) 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 umol/L or 2 times the site normal limit of AST or ALT activity.
- •Subject has systemic mastocytosis.
- •Subject has any condition that pre-disposes 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.
Investigators
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