Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-29 @ 1:07 PM
Study NCT ID:
NCT01344603
Status:
COMPLETED
Last Update Posted:
2011-04-29
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidural and Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cardiac surgery', 'cardiac anesthesia', 'epidural'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': "In the present study the investigators test the hypothesis that the epidural anesthesia added on the general anesthesia is able to improve patient's outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing cardiac surgery\n* adult (\\>18y)\n* sternotomy\n\nExclusion Criteria:\n\n* abnormal coagulation profile\n* antiplatelet medications (other than aspirin)\n* ongoing anticoagulation'}, 'identificationModule': {'nctId': 'NCT01344603', 'briefTitle': 'Epidural and Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Epidural Analgesia in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'HSR epi CCH 38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'epidural'}, {'label': 'standard'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Università Vita-Salute San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Landoni Giovanni', 'oldOrganization': 'Vita-Salute University of Milano, Italy'}}}}