Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-01-17 @ 11:58 AM
Study NCT ID:
NCT06475612
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071459', 'term': 'Death Domain'}], 'ancestors': [{'id': 'D000071458', 'term': 'Death Domain Superfamily'}, {'id': 'D054730', 'term': 'Protein Interaction Domains and Motifs'}, {'id': 'D000072417', 'term': 'Protein Domains'}, {'id': 'D000072416', 'term': 'Protein Structural Elements'}, {'id': 'D011487', 'term': 'Protein Conformation'}, {'id': 'D008968', 'term': 'Molecular Conformation'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40068}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality outcome', 'timeFrame': 'Through hospital stay of patients, an average of 14 days.', 'description': 'Mortality outcome of trauma patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma Injury']}, 'descriptionModule': {'briefSummary': 'Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021 Of these, 41,131 were adult patients aged 20 years and older. After excluding patients with burns (n = 1,040), hanging injuries (n = 19), drowning (n = 3), and unavailable laboratory data (n = 1), a final study population of 40,068 patients was analyzed. Within this cohort, there were 818 deaths, and 39,250 patients survived.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study includes all patients aged equal to or over twenty who had trauma.\n\nExclusion Criteria:\n\n* Patients with burns.\n* Patients with hangings.\n* Patients with drowning.\n* Patients with with unavailable laboratory data.'}, 'identificationModule': {'nctId': 'NCT06475612', 'briefTitle': 'Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Using the Geriatric Trauma Outcome Score (GTOS) to Stratify the Mortality Risk of Adult Trauma Patients', 'orgStudyIdInfo': {'id': '202400775B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trauma Patients', 'description': 'The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021. Of these, 40,068 were adult patients aged 20 years and older.', 'interventionNames': ['Other: Death', 'Other: Survival']}], 'interventions': [{'name': 'Death', 'type': 'OTHER', 'description': 'Mortality group.', 'armGroupLabels': ['Trauma Patients']}, {'name': 'Survival', 'type': 'OTHER', 'description': 'Survival group.', 'armGroupLabels': ['Trauma Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}