Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 4:15 PM
Study NCT ID:
NCT07093658
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High vs Low Fall Injuries in Asia: 7-Year Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59099}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': '30-day', 'description': '30-day mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trauma', 'Fall injury'], 'conditions': ['Fall Injury', 'Trauma']}, 'referencesModule': {'references': [{'pmid': '19388920', 'type': 'BACKGROUND', 'citation': 'Kim J, Shin SD, Im TH, Kug Jong Lee, Ko SB, Park JO, Ahn KO, Song KJ. Development and validation of the Excess Mortality Ratio-adjusted Injury Severity Score Using the International Classification of Diseases 10th Edition. Acad Emerg Med. 2009 May;16(5):454-464. doi: 10.1111/j.1553-2712.2009.00412.x.'}, {'pmid': '28792281', 'type': 'BACKGROUND', 'citation': 'Kong SY, Shin SD, Tanaka H, Kimura A, Song KJ, Shaun GE, Chiang WC, Kajino K, Jamaluddin SF, Wi DH, Park JO, Moon SW, Ro YS, Cone DC, Holmes JF Jr. Pan-Asian Trauma Outcomes Study (PATOS): Rationale and Methodology of an International and Multicenter Trauma Registry. Prehosp Emerg Care. 2018 Jan-Feb;22(1):58-83. doi: 10.1080/10903127.2017.1347224. Epub 2017 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter study revealed a declining overall incidence of fall-related injuries, accompanied by a rising proportion of high falls, predominantly among non-elderly males. Mortality risk increased significantly at fall heights of 3 and 6 meters, supporting current field triage thresholds. Across both high and low falls, lower SpO₂ and GCS were key predictors of 30-day mortality, with head injury being an additional risk factor in low fall cases'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included adult patients (aged ≥18 years) who were transported by emergency medical services (EMS) between January 2016 and December 2022. Patients were excluded if they had missing data on age, sex, injury mechanism, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), oxygen saturation (SpO₂), Glasgow Coma Scale (GCS), Abbreviated Injury Scale (AIS) for each body region, Injury Severity Score (ISS), Revised Trauma Score (RTS), or fall height. In addition, patients with missing records of 30-day mortality were excluded from the mortality cohort analysis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study included adult patients (aged ≥18 years) who were transported by emergency medical services (EMS) between January 2016 and December 2022.\n* Fall injury patients\n\nExclusion Criteria:\n\n* missing data on age, sex, injury mechanism, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), oxygen saturation (SpO₂), Glasgow Coma Scale (GCS), Abbreviated Injury Scale (AIS) for each body region, Injury Severity Score (ISS), Revised Trauma Score (RTS), or fall height\n* missing records of 30-day mortality'}, 'identificationModule': {'nctId': 'NCT07093658', 'briefTitle': 'High vs Low Fall Injuries in Asia: 7-Year Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'Epidemiology and Outcome of High Versus Low Fall Injury in Asia Countries: A 7-year Multicenter Cohort Study', 'orgStudyIdInfo': {'id': '24MMHIS447e'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low fall injury group', 'interventionNames': ['Other: High fall injury group']}], 'interventions': [{'name': 'High fall injury group', 'type': 'OTHER', 'description': 'High fall injury group', 'armGroupLabels': ['Low fall injury group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Tse-Hao Chen', 'investigatorAffiliation': 'Mackay Memorial Hospital'}}}}