PolytraumaNCT04335838
Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients.
An observational study of Polytrauma and Traumatic Brain Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma, Traumatic Brain Injury
- What is being tested?
- retrospective analysis
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2012to Dec 2015
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Retrospective analysis of polytrauma patients.
Who may be able to join
- ISS >16 points
- AIS >3 in one body region
- at least 2 body regions affected
Who cannot join
- patients younger than 18 years of age
- isolated traumatic brain injury
- minor injuries (AIS <3 or ISS <16 points)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Traumatology
Vienna, 1090
About this study
Official title: Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients. Experiences From a Level I Trauma Center.
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.
- Conditions
- Polytrauma, Traumatic Brain Injury
- Being tested
- retrospective analysis
- Keywords
- prognostic factors, New Berlin Definition, Polytrauma
- Medical subject headings
- Multiple Trauma, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysisOther
The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.
| Study group | Role | What they receive |
|---|---|---|
| Polytrauma Patients | Patients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Receives: Other: retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality in polytrauma patients.
Measured: January 1, 2012 to December 31, 2015
Secondary outcomes (1)
Possible prognostic factors influencing the outcome of polytrauma patients.
Evaluation of concomitant traumatic brain injury, resuscitation, injury severity and trauma mechanisms in polytrauma patients.
Measured: Januar 1, 2012 to December 31, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Valerie Weihs, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335838
- Sponsor's protocol ID
- 1816/2016
- Status last verified
- Nov 2024
- First submitted
- 3 Apr 2020
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age, Traumatic Brain Injury and Injury Severity as Independent Risk Factors for In-Hospital Mortality in Polytrauma Patients. Experiences From a Level I Trauma Center.
- ClinicalTrials.gov ID
- NCT04335838
- Acronym / sponsor ID
- 1816/2016
- Conditions
- Polytrauma, Traumatic Brain Injury
- Keywords
- prognostic factors, New Berlin Definition, Polytrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Apr 2020 (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.
In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS>16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. Possible prognostic factors were evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polytrauma Patients | – | Other: retrospective analysisPatients with an ISS >16 points, an AIS >3 in one body region and at least 2 different body regions affected were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of polytrauma patients.
Key inclusion criteria (3 listed)
- ISS >16 points
- AIS >3 in one body region
- at least 2 body regions affected
Key exclusion criteria (3 listed)
- patients younger than 18 years of age
- isolated traumatic brain injury
- minor injuries (AIS <3 or ISS <16 points)
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 |
|---|---|---|
| retrospective analysisThe investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients. | Other | Polytrauma Patients |
Primary outcome
In-hospital mortality in polytrauma patients.
Time frame: January 1, 2012 to December 31, 2015
1 secondary outcome
Possible prognostic factors influencing the outcome of polytrauma patients.
Time frame: Januar 1, 2012 to December 31, 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polytrauma and Traumatic Brain Injury, run by Medical University of Vienna 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-hospital mortality in polytrauma patients. (time frame: January 1, 2012 to December 31, 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.