Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT00301535
Status:
UNKNOWN
Last Update Posted:
2008-05-16
First Post:
2006-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096798', 'term': 'HBOC 201'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-15', 'studyFirstSubmitDate': '2006-03-09', 'studyFirstSubmitQcDate': '2006-03-10', 'lastUpdatePostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Graft', 'memory loss after cardiac surgery', 'side effects of bypass'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is between the ages of 18 and 80.\n* Subject is an acceptable candidate for CABG.\n* Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.\n* Subject signs informed consent\n* Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.\n\nExclusion Criteria:\n\n* Pre-operative myocardial infarction, defined as CK-MB level \\> 2 times upper limit of normal 24 hours prior to CABG surgery.\n* Renal failure defined as serum creatinine greater 220 µmol/L\n* Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).\n* Active infection.\n* History of prior stroke within last six months or history of prior stroke with residual neurological deficit.\n* Transient Ischemic attack within last 6 months.\n* Subject has a history of coagulopathy.\n* Subject is pregnant or currently breastfeeding.\n* History of allergy to beef products.\n* Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.L/min/m2 despite the use of vasopressors.\n* Underlying medical conditions that would limit subject's life expectancy to less than 12 months.\n* Severe pulmonary disease \\[based upon clinical diagnosis or pulmonary function tests (FEV \\<1 liter), if available\\] that may interfere with weaning subject from ventilator.\n* History of acute central nervous disorder (e.g., seizure or traumatic injury).\n* Severe hypertension (≥ 160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.\n* Severe liver dysfunction as defined by total bilirubin ≥ 51 µmol/L or 2 times the site normal limit of AST or ALT activity.\n* Subject has systemic mastocytosis.\n* 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.\n* Subject has participated in another investigational drug, biologic or device study within 30 days prior to study enrollment."}, 'identificationModule': {'nctId': 'NCT00301535', 'briefTitle': 'A Study of Hemopure® to Enhance Tissue Preservation During Cardiopulmonary Bypass Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biopure Corporation'}, 'officialTitle': 'Enhancement of Tissue Preservation During Cardiopulmonary Bypass With HBOC-201 (Registry Study)', 'orgStudyIdInfo': {'id': 'BIOEU003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: HBOC-201 (hemoglobin glutamer-250 bovine)']}, {'type': 'NO_INTERVENTION', 'label': '2'}], 'interventions': [{'name': 'HBOC-201 (hemoglobin glutamer-250 bovine)', 'type': 'DRUG', 'description': 'HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '552 36', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Julia Tzelepi, MD', 'role': 'CONTACT', 'email': 'ktzelepipal@yahoo.gr'}, {'name': 'Antonis Pitsis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Thessaloniki Heart Institute - St. Luke's Hospital", 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Ronel Snyman', 'role': 'CONTACT', 'email': 'research.jhb@mweb.co.za'}, {'name': 'Martin Sussman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christopher A Hammond, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Milpark Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': 'OX3 9DU', 'city': 'Headington', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephen Westaby, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oxford Heart Centre - John Radcliffe Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}], 'centralContacts': [{'name': 'Tiana Gorham', 'role': 'CONTACT', 'email': 'tgorham@biopure.com'}], 'overallOfficials': [{'name': 'A. Gerson Greenburg, MD, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biopure Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biopure Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biopure', 'oldOrganization': 'Biopure'}}}}