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A 13-years Nationwide Study of Alpine Accidents in Austria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755050
Recruitment Status : Active, not recruiting
First Posted : November 27, 2018
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
Institute of Mountain Emergency Medicine
Information provided by (Responsible Party):
Medical University Innsbruck

Tracking Information
First Submitted Date November 26, 2018
First Posted Date November 27, 2018
Last Update Posted Date September 8, 2021
Actual Study Start Date December 22, 2018
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2018)
  • Number of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    The number of persons which suffered one of the specified accidents. (n/year)
  • Gender of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    Gender male/female or non specified which suffered one of the specified accidents. (n/year)
  • Mortality of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
Original Primary Outcome Measures
 (submitted: November 26, 2018)
  • Number of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    The number of persons (n/year) which suffered one of the specified accidents.
  • Gender of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    Gender male/female or non specified which suffered one of the specified accidents.
  • Mortality of persons suffered an accident in Alpine Mountains in Austria [ Time Frame: 2005-2018 ]
    Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
Change History
Current Secondary Outcome Measures
 (submitted: November 27, 2018)
  • Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    (n/year) treated at Medical University of Innsbruck
  • Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    male/female, unspecified treated at Medical University of Innsbruck (n/year)
  • Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    Injury severity score of suffered injury (ISS=AIS*AIS)
  • Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)
  • Type of evacuation [ Time Frame: 2005-2018 ]
    Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) (n/year)
  • Mortality depending on evacuation type [ Time Frame: 2005-2018 ]
    Number of fatalities depending on type of evacuation (n/year)
Original Secondary Outcome Measures
 (submitted: November 26, 2018)
  • Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    (n/year) treated at Medical University of Innsbruck
  • Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    male/female, unspecified treated at Medical University of Innsbruck
  • Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    Injury severity score of suffered injury (ISS=AIS*AIS)
  • Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria. [ Time Frame: 2005-2018 ]
    Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)
  • Type of evacuation and mortality [ Time Frame: 2005-2018 ]
    Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) and the mortality for each group (deceased/n per year)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A 13-years Nationwide Study of Alpine Accidents in Austria
Official Title 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
Brief Summary

Brief Summary:

This 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.

Detailed Description

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.

The method to collect data and to analyze is the same than in AN4757 315/4.4 (NCT03405467).

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All Patients in the two databases eligible for the searched injury patterns.
Condition
  • Alpine Accident
  • Sleighing
  • Climbing
  • Cycling
  • Canyoning
  • Hiking
  • Snowshoeing
  • Alpine Water-sport
  • Skiing/Snowboarding
Intervention Other: general and specific data
General and specific data collected
Study Groups/Cohorts
  • Sleigh Accident
    Accident while using a sleigh
    Intervention: Other: general and specific data
  • Climbing Accident
    Accident occurred while climbing (rock, ice)
    Intervention: Other: general and specific data
  • Cycle Accident
    Accident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike)
    Intervention: Other: general and specific data
  • Canyoning Accident
    Accident occurred while doing canyoning
    Intervention: Other: general and specific data
  • Hiking Accident
    Accident occurred while hiking in mountainous area.
    Intervention: Other: general and specific data
  • Snowshoeing Accident
    Accident occurred while doing Snowshoeing
    Intervention: Other: general and specific data
  • Mountainous Water-sport Accident
    Accident occurred while doing any type of Water-sport (e.g. canoeing, kayaking, tubing, swimming) in mountainous environment.
    Intervention: Other: general and specific data
  • Skiing/Snowboarding
    Accident occurred while using ski or a snowboard either in backcountry or on ski slope
    Intervention: Other: general and specific data
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 26, 2018)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with the criteria for an alpine accident characteristics described under "Conditions".

Exclusion Criteria:

  • All patients without accident characteristics described under "Conditions".
  • All patients which suffered an accident not in alpine environment.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03755050
Other Study ID Numbers AN2016-0018 358/4.8 390/5.5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Medical University Innsbruck
Original Responsible Party Same as current
Current Study Sponsor Medical University Innsbruck
Original Study Sponsor Same as current
Collaborators Institute of Mountain Emergency Medicine
Investigators
Principal Investigator: Mathias Ströhle General and Surgical Critical Care Medicine, Medical University of Innsbruck
PRS Account Medical University Innsbruck
Verification Date September 2021