Enhancement of Tissue Preservation During Cardiopulmonary Bypasswith HemoPure®

Phase 1

• Conditions: Patients needing multi-vessel treatment by coronary artery bypass graft (CABG) surgery

• Registration Number: EUCTR2005-003639-30-GB
• Lead Sponsor: Biopure Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-26
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified