Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 5:39 PM
Study NCT ID:
NCT01298050
Status:
UNKNOWN
Last Update Posted:
2011-08-04
First Post:
2011-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refractory IHCA and OHCA Treated With ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 days survival', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Neurologic recovery', 'timeFrame': '28 days', 'description': 'Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.'}, {'measure': 'Cardiac recovery', 'timeFrame': '28 days', 'description': 'Measured by echocardiography'}, {'measure': 'Six months survival with minimal neurologic impairment', 'timeFrame': '180 days', 'description': 'survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults 18-75 years old, community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-75 years old\n* In and out of hospital Witnessed Cardiac Arrest\n* No-flow time \\< 5 min. or VF,VT,TP as rhythm of presentation\n* Low-flow time \\< 45 min.\n* End Tidal CO2 \\> 10 after 20 min.of CPR\n\nExclusion Criteria:\n\n* Comorbidities such:\n* Terminal Malignancy\n* Aortic Dissection\n* Severe Cardiac Failure without transplant indication\n* Severe Aortic Valve Failure\n* Known Severe Peripheral arteriopathy'}, 'identificationModule': {'nctId': 'NCT01298050', 'acronym': 'SEAC', 'briefTitle': 'Refractory IHCA and OHCA Treated With ECMO', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.', 'orgStudyIdInfo': {'id': 'AOSG-TICCH-01-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Extracorporeal Membrane Oxygenation', 'description': 'All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.', 'interventionNames': ['Procedure: ECMO']}], 'interventions': [{'name': 'ECMO', 'type': 'PROCEDURE', 'description': 'Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia', 'armGroupLabels': ['Extracorporeal Membrane Oxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20052', 'city': 'Monza', 'state': 'MB', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Leonello Avalli, MD', 'role': 'CONTACT', 'email': 'l.avalli@hsgerardo.org', 'phone': '0039392334330'}, {'name': 'Roberto Fumagalli, MD', 'role': 'CONTACT', 'email': 'r.fumagalli@hsgerardo.org', 'phone': '0039392339294'}, {'name': 'Leonello Avalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Gerardo Hospital', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Leonelllo Avalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale San Gerardo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale San Gerardo. S.S.U.E.M. 118 Brianza', 'class': 'UNKNOWN'}, {'name': 'Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Roberto Fumagalli', 'oldOrganization': 'University of Milano Bicocca'}}}}