Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-27 @ 1:39 PM
Study NCT ID:
NCT04723992
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center
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': 'ACTUAL', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality in polytrauma patients.', 'timeFrame': 'January 1st 1992 to December 31st 2019'}, {'measure': 'Possible prognostic factors influencing the outcome of polytrauma patients.', 'timeFrame': 'January 1st 1992 to December 31st 2019', 'description': 'Evaluation of concomitant traumatic brain injury, resuscitation, injury severity and trauma mechanisms in polytrauma patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polytrauma']}, 'referencesModule': {'references': [{'pmid': '35412071', 'type': 'DERIVED', 'citation': 'Weihs V, Frenzel S, Dedeyan M, Hruska F, Staats K, Hajdu S, Negrin LL, Aldrian S. 25-Year experience with adult polytraumatized patients in a European level 1 trauma center: polytrauma between 1995 and 2019. What has changed? A retrospective cohort study. Arch Orthop Trauma Surg. 2023 May;143(5):2409-2415. doi: 10.1007/s00402-022-04433-1. Epub 2022 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 1992 to December 2019. Patients with an ISS\\>16 points, an AIS \\>3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective analysis of polytrauma patients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ISS \\>16 points\n* AIS \\>3 in one body region\n* at least 2 body regions affected\n\nExclusion Criteria:\n\n* patients younger than 18 years of age\n* isolated traumatic brain injury\n* minor injuries (AIS \\<3 or ISS \\<16 points)'}, 'identificationModule': {'nctId': 'NCT04723992', 'briefTitle': '25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': '25-Year Experience With Polytraumatized Patients in a Level 1 Trauma Center.: Polytrauma Between 1995 and 2019: What Has Changed', 'orgStudyIdInfo': {'id': '1146/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'retrospective analysis', 'type': 'OTHER', 'description': 'The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Traumatology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Dr. Valerie Weihs', 'investigatorAffiliation': 'Medical University of Vienna'}}}}