Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-23 @ 8:57 PM
Study NCT ID:
NCT03755050
Status:
UNKNOWN
Last Update Posted:
2021-09-08
First Post:
2018-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 13-years Nationwide Study of Alpine Accidents in Austria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2018-11-26', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2018', 'description': 'The number of persons which suffered one of the specified accidents. (n/year)'}, {'measure': 'Gender of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2018', 'description': 'Gender male/female or non specified which suffered one of the specified accidents. (n/year)'}, {'measure': 'Mortality of persons suffered an accident in Alpine Mountains in Austria', 'timeFrame': '2005-2018', 'description': 'Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.'}], 'secondaryOutcomes': [{'measure': 'Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.', 'timeFrame': '2005-2018', 'description': '(n/year) treated at Medical University of Innsbruck'}, {'measure': 'Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.', 'timeFrame': '2005-2018', 'description': 'male/female, unspecified treated at Medical University of Innsbruck (n/year)'}, {'measure': 'Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.', 'timeFrame': '2005-2018', 'description': 'Injury severity score of suffered injury (ISS=AIS\\*AIS)'}, {'measure': 'Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.', 'timeFrame': '2005-2018', 'description': 'Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)'}, {'measure': 'Type of evacuation', 'timeFrame': '2005-2018', 'description': 'Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) (n/year)'}, {'measure': 'Mortality depending on evacuation type', 'timeFrame': '2005-2018', 'description': 'Number of fatalities depending on type of evacuation (n/year)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alpine Accident', 'Sleighing', 'Climbing', 'Cycling', 'Canyoning', 'Hiking', 'Snowshoeing', 'Alpine Water-sport', 'Skiing/Snowboarding']}, 'referencesModule': {'references': [{'pmid': '34667014', 'type': 'DERIVED', 'citation': 'Rugg CD, Malzacher T, Ausserer J, Rederlechner A, Paal P, Strohle M. Gender differences in snowboarding accidents in Austria: a 2005-2018 registry analysis. BMJ Open. 2021 Oct 19;11(10):e053413. doi: 10.1136/bmjopen-2021-053413.'}]}, 'descriptionModule': {'briefSummary': "Brief Summary:\n\nThis observational study intends to analyze the characteristic of specific accidents happened in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are accidents while using a sleigh, climbing accidents, cycle accidents, canyoning accidents, hiking accidents, snowshoeing accidents, water-sport accidents, ski and snowboard accidents.", 'detailedDescription': "The data are collected retrospectively from the database of Austrian alpine police force. These data are analyzed. The information from this database (scene of accident, weather, daytime…) is compared to secondary data collected from the University Hospital of Innsbruck. The comparison of both databases was approved by the Austrian Data Protection Agency. The goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.\n\nThe method to collect data and to analyze is the same than in AN4757 315/4.4 (NCT03405467)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All Patients in the two databases eligible for the searched injury patterns.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with the criteria for an alpine accident characteristics described under "Conditions".\n\nExclusion Criteria:\n\n* All patients without accident characteristics described under "Conditions".\n* All patients which suffered an accident not in alpine environment.'}, 'identificationModule': {'nctId': 'NCT03755050', 'briefTitle': 'A 13-years Nationwide Study of Alpine Accidents in Austria', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'A 13-years Nationwide Retrospective Observational Study of Alpine Accidents in Austria - Sleighing, Skiing, Snowboarding, Snowshoeing, Climbing, Hiking, Cycling, Mountain Biking, Canyoning and Alpine Watersport Activities', 'orgStudyIdInfo': {'id': 'AN2016-0018 358/4.8 390/5.5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sleigh Accident', 'description': 'Accident while using a sleigh', 'interventionNames': ['Other: general and specific data']}, {'label': 'Climbing Accident', 'description': 'Accident occurred while climbing (rock, ice)', 'interventionNames': ['Other: general and specific data']}, {'label': 'Cycle Accident', 'description': 'Accident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike)', 'interventionNames': ['Other: general and specific data']}, {'label': 'Canyoning Accident', 'description': 'Accident occurred while doing canyoning', 'interventionNames': ['Other: general and specific data']}, {'label': 'Hiking Accident', 'description': 'Accident occurred while hiking in mountainous area.', 'interventionNames': ['Other: general and specific data']}, {'label': 'Snowshoeing Accident', 'description': 'Accident occurred while doing Snowshoeing', 'interventionNames': ['Other: general and specific data']}, {'label': 'Mountainous Water-sport Accident', 'description': 'Accident occurred while doing any type of Water-sport (e.g. canoeing, kayaking, tubing, swimming) in mountainous environment.', 'interventionNames': ['Other: general and specific data']}, {'label': 'Skiing/Snowboarding', 'description': 'Accident occurred while using ski or a snowboard either in backcountry or on ski slope', 'interventionNames': ['Other: general and specific data']}], 'interventions': [{'name': 'general and specific data', 'type': 'OTHER', 'description': 'General and specific data collected', 'armGroupLabels': ['Canyoning Accident', 'Climbing Accident', 'Cycle Accident', 'Hiking Accident', 'Mountainous Water-sport Accident', 'Skiing/Snowboarding', 'Sleigh Accident', 'Snowshoeing Accident']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'General and Surgical Critical Care Medicine, Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Mathias Ströhle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General and Surgical Critical Care Medicine, Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}