Alpine AccidentNCT03755050
A 13-years Nationwide Study of Alpine Accidents in Austria
An observational study of Alpine Accident and Sleighing, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alpine Accident, Sleighing, Climbing
- What is being tested?
- general and specific data
- How many people
- 20,000 participants
- Where
- 1 siteAustria
- Study dates
- 22 Dec 2018to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Patients in the two databases eligible for the searched injury patterns.
Who may be able to join
- All patients with the criteria for an alpine accident characteristics described under "Conditions".
Who cannot join
- All patients without accident characteristics described under "Conditions".
- All patients which suffered an accident not in alpine environment.
Trial locations and contacts
1 site in 1 country.
Austria1 site
General and Surgical Critical Care Medicine, Medical University of Innsbruck
Innsbruck, 6020
About this study
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:
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.
Read the 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).
- Being tested
- general and specific data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general and specific dataOther
General and specific data collected
| Study group | Role | What they receive |
|---|---|---|
| Sleigh Accident | Accident while using a sleigh Receives: Other: general and specific data | |
| Climbing Accident | Accident occurred while climbing (rock, ice) Receives: Other: general and specific data | |
| Cycle Accident | Accident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike) Receives: Other: general and specific data | |
| Canyoning Accident | Accident occurred while doing canyoning Receives: Other: general and specific data | |
| Hiking Accident | Accident occurred while hiking in mountainous area. Receives: Other: general and specific data | |
| Snowshoeing Accident | Accident occurred while doing Snowshoeing Receives: 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. Receives: Other: general and specific data | |
| Skiing/Snowboarding | Accident occurred while using ski or a snowboard either in backcountry or on ski slope Receives: Other: general and specific data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of persons suffered an accident in Alpine Mountains in Austria
The number of persons which suffered one of the specified accidents. (n/year)
Measured: 2005-2018
Gender of persons suffered an accident in Alpine Mountains in Austria
Gender male/female or non specified which suffered one of the specified accidents. (n/year)
Measured: 2005-2018
Mortality of persons suffered an accident in Alpine Mountains in Austria
Number of persons deceased (deceased/n per year) which suffered one of the specified accidents.
Measured: 2005-2018
Secondary outcomes (6)
Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
(n/year) treated at Medical University of Innsbruck
Measured: 2005-2018
Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
male/female, unspecified treated at Medical University of Innsbruck (n/year)
Measured: 2005-2018
Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Injury severity score of suffered injury (ISS=AIS*AIS)
Measured: 2005-2018
Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Abbreviated Injury Severity Scale of suffered injury (1-6 points; scale - minor, moderate, serious, severe, critical, maximum)
Measured: 2005-2018
Type of evacuation
Type of evacuation (terrestrial, helicopter, combined terrestrial and helicopter) (n/year)
Measured: 2005-2018
Mortality depending on evacuation type
Number of fatalities depending on type of evacuation (n/year)
Measured: 2005-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start22 Dec 2018
- Primary completion27 May 2020
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alpine AccidentStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Responsible party
- Sponsor
- Investigators
- Mathias Ströhle, Principal investigator, General and Surgical Critical Care Medicine, Medical University of Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755050
- Sponsor's protocol ID
- AN2016-0018 358/4.8 390/5.5
- Status last verified
- Sep 2021
- First submitted
- 26 Nov 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34667014
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03755050
- Acronym / sponsor ID
- AN2016-0018 358/4.8 390/5.5
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Institute of Mountain Emergency Medicine
- Study start
- 22 Dec 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sleigh Accident | – | Other: general and specific dataAccident while using a sleigh |
| Climbing Accident | – | Other: general and specific dataAccident occurred while climbing (rock, ice) |
| Cycle Accident | – | Other: general and specific dataAccident occurred while using any form of cycle in the mountains (e.g. bike, mountainbike, e-bike) |
| Canyoning Accident | – | Other: general and specific dataAccident occurred while doing canyoning |
| Hiking Accident | – | Other: general and specific dataAccident occurred while hiking in mountainous area. |
| Snowshoeing Accident | – | Other: general and specific dataAccident occurred while doing Snowshoeing |
| Mountainous Water-sport Accident | – | Other: general and specific dataAccident occurred while doing any type of Water-sport (e.g. canoeing, kayaking, tubing, swimming) in mountainous environment. |
| Skiing/Snowboarding | – | Other: general and specific dataAccident occurred while using ski or a snowboard either in backcountry or on ski slope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Patients in the two databases eligible for the searched injury patterns.
Key inclusion criteria (1 listed)
- All patients with the criteria for an alpine accident characteristics described under "Conditions".
Key exclusion criteria (2 listed)
- All patients without accident characteristics described under "Conditions".
- All patients which suffered an accident not in alpine environment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general and specific dataGeneral and specific data collected | Other | Canyoning Accident, Climbing Accident, Cycle Accident, Hiking Accident, Mountainous Water-sport Accident, Skiing/Snowboarding, Sleigh Accident, Snowshoeing Accident |
Primary outcome
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.
6 secondary outcomes
Number of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Time frame: 2005-2018
Gender of patients treated per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Time frame: 2005-2018
Injury severity score (ISS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Time frame: 2005-2018
Abbreviated Injury severity scale (AIS) per injury pattern at Medical University of Innsbruck, a major trauma center in western Austria.
Time frame: 2005-2018
Type of evacuation
Time frame: 2005-2018
Mortality depending on evacuation type
Time frame: 2005-2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 34667014Rugg 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Ströhle principal investigator
General and Surgical Critical Care Medicine, Medical University of Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alpine Accident and Sleighing, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of persons suffered an accident in Alpine Mountains in Austria (time frame: 2005-2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03755050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.