Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT00862160
Status:
UNKNOWN
Last Update Posted:
2009-10-07
First Post:
2009-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020766', 'term': 'Intracranial Embolism'}, {'id': 'D004618', 'term': 'Embolism, Air'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-06', 'studyFirstSubmitDate': '2009-03-13', 'studyFirstSubmitQcDate': '2009-03-13', 'lastUpdatePostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fresh micro-lesions in cranial MRT', 'timeFrame': 'before and 72 h after CABG'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 days after CABG'}, {'measure': 'Neurological events', 'timeFrame': 'between CABG and discharge'}, {'measure': 'Neurocognitive function', 'timeFrame': 'before and 3-4 days after CABG and after 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['coronary artery bypass surgery', 'cardiopulmonary bypass', 'heart lung machine', 'acute cerebrovascular event', 'intracranial embolism', 'embolism, air', 'outcome assessment (health care)', 'neuropsychological tests', 'magnetic resonance imaging', 'saccadic eye movement test'], 'conditions': ['Coronary Artery Disease', 'Acute Cerebrovascular Accident', 'Intracranial Embolism', 'Embolism, Air']}, 'descriptionModule': {'briefSummary': 'The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.', 'detailedDescription': "Coronary artery bypass grafting with extracorporal circulation is established as the golden standard. The conventional cardiopulmonary bypass (CPB) system is associated with inflammatory reaction, hemolysis, hemodilution an disturbances of the blood coagulation system. Also it's well known that neurological disturbances caused by embolic material and air bubbles are potential risks of CPB. The new minimized perfusion circuit ROCsafeTM is a closed, reservoir-less, reduced prime, surface coated circuit, with optimized safety features in effectively eliminate both macro and micro air bubbles and should optimize the clinical outcome after CABG using cardiopulmonary bypass."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is older than 17 years\n* Patient is acceptable candidate for CABG operation\n* Patient or the patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.\n\nExclusion Criteria:\n\n* Ejection fraction less than 30 %\n* Valve surgery\n* Acute endocarditis or history of endocarditis\n* Cerebral ischemia within 4 weeks before surgery\n* Detection of intracardial thrombi in preoperative echocardiography\n* Stenosis of A. carotis int. greater than 70 %\n* Patients older than 80 years\n* Patients on dialysis\n* Acute myocardial ischemia or infarction within two weeks before inclusion\n* Markedly elevated baseline C-reactive protein (CRP) or leucocytosis\n* Cancer or immunologic diseases\n* Dysregulation of the coagulation cascade (not concerning INR or PTT under cumarin or heparin treatment)\n* Intake of steroids or NSAR\n* Female of childbearing potential\n* Participation in an other study\n* Contraindication for MRI (e.g. pacemaker, any kind of implanted metal)\n* Claustrophobia"}, 'identificationModule': {'nctId': 'NCT00862160', 'acronym': 'ROCsafeTM', 'briefTitle': 'Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Acute Cerebrovascular Events During Extracorporeal Circulation a Comparison of New Minimized Perfusion Circuit to Standard Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'T201E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'using minimized cardiopulmonary bypass circuit ROCsafeTM', 'interventionNames': ['Device: ROCsafeTM']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'using standard cardiopulmonary bypass circuit'}], 'interventions': [{'name': 'ROCsafeTM', 'type': 'DEVICE', 'description': 'using minimized perfusion circuit while CABG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38126', 'city': 'Braunschweig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfgang Harringer, PD Dr. med.', 'role': 'CONTACT', 'email': 'w.harringer@klinikum-braunschweig.de', 'phone': '0049-531-595-2213'}, {'name': 'Aschraf El Essawi, Dr. med.', 'role': 'CONTACT', 'email': 'a.elessawi@klinikum-braunschweig.de', 'phone': '0049-531-595-2213'}, {'name': 'Wolfgang Harringer, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Uwe Schönrock', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aschraf El Essawi, Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Klinikum Braunschweig, Department of Cardiothoracic Surgery', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ingo Kutschka, PD Dr. med.', 'role': 'CONTACT', 'email': 'kutschka.ingo@mh-hannover.de', 'phone': '0049-511-532-2154'}, {'name': 'Christian Hagl, PD Dr. med.', 'role': 'CONTACT', 'email': 'hagl.christian@mh-hannover.de', 'phone': '0049-511-532-3447'}, {'name': 'Ingo Kutschka, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian Hagl, PD Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Axel Haverich, Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hannover Medical School, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Ingo Kutschka, PD Dr. med.', 'role': 'CONTACT', 'email': 'kutschka.ingo@mh-hannover.de', 'phone': '0049-511-532-2154'}], 'overallOfficials': [{'name': 'Ingo Kutschka, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academic Teaching Hospital Braunschweig', 'class': 'OTHER'}, {'name': 'Terumo Europe N.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'PD Dr. med. Ingo Kutschka', 'oldOrganization': 'HannoverMS, Clinic of Cardiac Thoracic Transplantation and Vascular Surgery'}}}}