<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755050</url>
  </required_header>
  <id_info>
    <org_study_id>AN2016-0018 358/4.8 390/5.5</org_study_id>
    <nct_id>NCT03755050</nct_id>
  </id_info>
  <brief_title>A 13-years Nationwide Study of Alpine Accidents in Austria</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Mountain Emergency Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary:&#xD;
&#xD;
      This observational study intends to analyze the characteristic of specific accidents happened&#xD;
      in Austrian's mountainous regions. The mechanisms of accidents which are evaluated are&#xD;
      accidents while using a sleigh, climbing accidents, cycle accidents, canyoning accidents,&#xD;
      hiking accidents, snowshoeing accidents, water-sport accidents, ski and snowboard accidents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The data are collected retrospectively from the database of Austrian alpine police force.&#xD;
      These data are analyzed. The information from this database (scene of accident, weather,&#xD;
      daytime…) is compared to secondary data collected from the University Hospital of Innsbruck.&#xD;
      The comparison of both databases was approved by the Austrian Data Protection Agency. The&#xD;
      goal of the study is to give detailed information of circumstances leading to accident and&#xD;
      give medical information of the patient's condition and his outcome.&#xD;
&#xD;
      The method to collect data and to analyze is the same than in AN4757 315/4.4 (NCT03405467).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 22, 2018</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Actual">May 27, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of persons suffered an accident in Alpine Mountains in Austria</measure>
    <time_frame>2005-2018</time_frame>
    <description>The number of persons which suffered one of the specified accidents. (n/year)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gender of persons suffered an accident in Alpine Mountains in Austria</measure>
    <time_frame>2005-2018</time_frame>
    <description>Gender male/female or non specified which suffered one of the specified accidents. (n/year)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality of persons suffered an accident in Alpine Mountains in Austria</measure>
    <time_frame>2005-2018</time_frame>
    <description>Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.</measure>
    <time_frame>2005-2018</time_frame>
    <description>(n/year) treated at Medical University of Innsbruck</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.</measure>
    <time_frame>2005-2018</time_frame>
    <description>male/female, unspecified treated at Medical University of Innsbruck (n/year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.</measure>
    <time_frame>2005-2018</time_frame>
    <description>Injury severity score of suffered injury (ISS=AIS*AIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.</measure>
    <time_frame>2005-2018</time_frame>
    <description>Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of evacuation</measure>
    <time_frame>2005-2018</time_frame>
    <description>Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) (n/year)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality depending on evacuation type</measure>
    <time_frame>2005-2018</time_frame>
    <description>Number of fatalities depending on type of evacuation (n/year)</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">20000</enrollment>
  <condition>Alpine Accident</condition>
  <condition>Sleighing</condition>
  <condition>Climbing</condition>
  <condition>Cycling</condition>
  <condition>Canyoning</condition>
  <condition>Hiking</condition>
  <condition>Snowshoeing</condition>
  <condition>Alpine Water-sport</condition>
  <condition>Skiing/Snowboarding</condition>
  <arm_group>
    <arm_group_label>Sleigh Accident</arm_group_label>
    <description>Accident while using a sleigh</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Climbing Accident</arm_group_label>
    <description>Accident occurred while climbing (rock, ice)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycle Accident</arm_group_label>
    <description>Accident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Canyoning Accident</arm_group_label>
    <description>Accident occurred while doing canyoning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hiking Accident</arm_group_label>
    <description>Accident occurred while hiking in mountainous area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snowshoeing Accident</arm_group_label>
    <description>Accident occurred while doing Snowshoeing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mountainous Water-sport Accident</arm_group_label>
    <description>Accident occurred while doing any type of Water-sport (e.g. canoeing, kayaking, tubing, swimming) in mountainous environment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skiing/Snowboarding</arm_group_label>
    <description>Accident occurred while using ski or a snowboard either in backcountry or on ski slope</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>general and specific data</intervention_name>
    <description>General and specific data collected</description>
    <arm_group_label>Canyoning Accident</arm_group_label>
    <arm_group_label>Climbing Accident</arm_group_label>
    <arm_group_label>Cycle Accident</arm_group_label>
    <arm_group_label>Hiking Accident</arm_group_label>
    <arm_group_label>Mountainous Water-sport Accident</arm_group_label>
    <arm_group_label>Skiing/Snowboarding</arm_group_label>
    <arm_group_label>Sleigh Accident</arm_group_label>
    <arm_group_label>Snowshoeing Accident</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All Patients in the two databases eligible for the searched injury patterns.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with the criteria for an alpine accident characteristics described under&#xD;
             &quot;Conditions&quot;.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients without accident characteristics described under &quot;Conditions&quot;.&#xD;
&#xD;
          -  All patients which suffered an accident not in alpine environment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathias Ströhle</last_name>
    <role>Principal Investigator</role>
    <affiliation>General and Surgical Critical Care Medicine, Medical University of Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General and Surgical Critical Care Medicine, Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755050
org study id: AN2016-0018 358/4.8 390/5.5
nct id: NCT03755050
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Case-Only
time perspective: Retrospective
measure: Number of persons suffered an accident in Alpine Mountains in Austria
time frame: 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
time frame: 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
time frame: 2005-2018
description: Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
measure: Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
time frame: 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.
time frame: 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.
time frame: 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.
time frame: 2005-2018
description: Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)
measure: Type of evacuation
time frame: 2005-2018
description: Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) (n/year)
measure: Mortality depending on evacuation type
time frame: 2005-2018
description: Number of fatalities depending on type of evacuation (n/year)
arm group label: Sleigh Accident
description: Accident while using a sleigh
arm group label: Climbing Accident
description: Accident occurred while climbing (rock, ice)
arm group label: Cycle Accident
description: Accident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike)
arm group label: Canyoning Accident
description: Accident occurred while doing canyoning
arm group label: Hiking Accident
description: Accident occurred while hiking in mountainous area.
arm group label: Snowshoeing Accident
description: Accident occurred while doing Snowshoeing
arm group label: Mountainous Water-sport Accident
description: Accident occurred while doing any type of Water-sport (e.g. canoeing, kayaking, tubing, swimming) in mountainous environment.
arm group label: Skiing/Snowboarding
description: Accident occurred while using ski or a snowboard either in backcountry or on ski slope
intervention type: Other
intervention name: general and specific data
description: General and specific data collected
arm group label: Canyoning Accident
arm group label: Climbing Accident
arm group label: Cycle Accident
arm group label: Hiking Accident
arm group label: Mountainous Water-sport Accident
arm group label: Skiing/Snowboarding
arm group label: Sleigh Accident
arm group label: Snowshoeing Accident
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mathias Ströhle
role: Principal Investigator
affiliation: General and Surgical Critical Care Medicine, Medical University of Innsbruck
facility: 
country: Austria
responsible party type: Sponsor
sharing ipd: No