Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-01 @ 3:13 PM
Study NCT ID:
NCT05074095
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Urogenital Injuries in Polytraumatized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive factors for urogenital injuries', 'timeFrame': '5 years', 'description': 'This retrospective analysis is designed to identify predictors of urogenital injuries in polytrauma patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polytrauma']}, 'descriptionModule': {'briefSummary': 'Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.\n\nThe goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective analysis of polytrauma patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ISS (Injury severity score) \\> 15 points\n* Patient Age \\> 16\n* Fracture of the thoracic and/ or lumbar spine\n* Fracture of the pelvic girdle\n* at least one AIS (abbreviated injury scale) \\> 2\n\nExclusion Criteria:\n\n* ISS \\< 16 points\n* no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle\n* no AIS \\> 2\n* patient age under 16 years of age'}, 'identificationModule': {'nctId': 'NCT05074095', 'briefTitle': 'Analysis of Urogenital Injuries in Polytraumatized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors', 'orgStudyIdInfo': {'id': '229/20 S-EB'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with urogenital injuries', 'interventionNames': ['Other: retrospective analysis']}, {'label': '2', 'description': 'Patients without urogenital injuries', 'interventionNames': ['Other: retrospective analysis']}], 'interventions': [{'name': 'retrospective analysis', 'type': 'OTHER', 'armGroupLabels': ['1', '2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}