Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 8:17 PM
Study NCT ID:
NCT05794256
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genderspecific Differences in Hormone Levels After Trauma
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'within 1 year after trauma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polytrauma']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma.\n\nThis is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status.\n\nHormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. Furthermore a detailed questionnaire aims to answer any hormone-related health questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients suffering from severe trauma (ISS ≥ 16) or severe traumatic brain injury (AIS ≥3) will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polytrauma with ISS≥16,\n* severe traumatic brain injury (AIS ≥3)\n* over the age of 18\n* must reach emergency room alive\n\nExclusion Criteria:\n\n* pregnant patients\n* dead on arrival to the hospital\n* incarcerated patients\n* secondarily transferred patients'}, 'identificationModule': {'nctId': 'NCT05794256', 'acronym': 'SteroPoly', 'briefTitle': 'Genderspecific Differences in Hormone Levels After Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'A Prospective Analysis of the Gender Specific Role of Steroid Hormones on the Outcome on Patients After Polytrauma', 'orgStudyIdInfo': {'id': '2022-687-S-SR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No interventions are planned', 'type': 'OTHER', 'description': 'No interventions are planned'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Biberthaler, Prof.', 'role': 'CONTACT', 'phone': '+498941402126'}], 'facility': 'Technical University Munich', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Olivia Mair, MD', 'role': 'CONTACT', 'email': 'oliviaanna.mair@mri.tum.de', 'phone': '+498941409382'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}