Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-02 @ 6:18 PM
Study NCT ID:
NCT03006120
Status:
COMPLETED
Last Update Posted:
2017-01-02
First Post:
2016-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-30', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2016-12-28', 'lastUpdatePostDateStruct': {'date': '2017-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '01/01/2010- 31/10/2016'}]}, 'conditionsModule': {'conditions': ['Treatment Procedure', 'Mortality']}, 'descriptionModule': {'briefSummary': 'Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retroperitoneal hematoma following cardiac catheterization in our institution between January 2010 and October 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retroperitoneal hematoma following cardiac catheterization\n\nExclusion Criteria:\n\n* Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.'}, 'identificationModule': {'nctId': 'NCT03006120', 'briefTitle': 'Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}, 'orgStudyIdInfo': {'id': '2016.5/7-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Conservative management', 'interventionNames': ['Procedure: Retroperitoneal hematoma due to cardiac catheterization']}, {'label': 'Group 2', 'description': 'Angiografic stenting', 'interventionNames': ['Procedure: Retroperitoneal hematoma due to cardiac catheterization']}, {'label': 'Group 3', 'description': 'Surgery', 'interventionNames': ['Procedure: Retroperitoneal hematoma due to cardiac catheterization']}], 'interventions': [{'name': 'Retroperitoneal hematoma due to cardiac catheterization', 'type': 'PROCEDURE', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director,Depertmant of Gastroenterological Surgery, Principal Investigator, Clinical M.D', 'investigatorFullName': 'Ebubekir Gündeş', 'investigatorAffiliation': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}}}}