PolytraumaNCT05074095
Analysis of Urogenital Injuries in Polytraumatized Patients
An observational study of Polytrauma, run by Technical University of Munich.
Trial summary
Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polytrauma
- What is being tested?
- retrospective analysis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Feb 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Retrospective analysis of polytrauma patients.
Who may be able to join
- ISS (Injury severity score) > 15 points
- Patient Age > 16
- Fracture of the thoracic and/ or lumbar spine
- Fracture of the pelvic girdle
- at least one AIS (abbreviated injury scale) > 2
Who cannot join
- ISS < 16 points
- no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle
- no AIS > 2
- patient age under 16 years of age
About this study
Official title: Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors
Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.
The goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.
- Conditions
- Polytrauma
- Being tested
- retrospective analysis
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with urogenital injuries Receives: Other: retrospective analysis | |
| 2 | Patients without urogenital injuries Receives: Other: retrospective analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors for urogenital injuries
This retrospective analysis is designed to identify predictors of urogenital injuries in polytrauma patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion1 Feb 2021
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 Technical University of MunichThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074095
- Sponsor's protocol ID
- 229/20 S-EB
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors
- ClinicalTrials.gov ID
- NCT05074095
- Acronym / sponsor ID
- 229/20 S-EB
- Conditions
- Polytrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 12 Oct 2021 (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.
Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.
The goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: retrospective analysisPatients with urogenital injuries |
| 2 | – | Other: retrospective analysisPatients without urogenital injuries |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Retrospective analysis of polytrauma patients.
Key inclusion criteria (5 listed)
- ISS (Injury severity score) > 15 points
- Patient Age > 16
- Fracture of the thoracic and/ or lumbar spine
- Fracture of the pelvic girdle
- at least one AIS (abbreviated injury scale) > 2
Key exclusion criteria (4 listed)
- ISS < 16 points
- no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle
- no AIS > 2
- patient age under 16 years of age
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 analysis | Other | 1, 2 |
Primary outcome
Predictive factors for urogenital injuries
Time frame: 5 years
This retrospective analysis is designed to identify predictors of urogenital injuries in polytrauma patients
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 12 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polytrauma, run by Technical University of Munich.
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 5 inclusion and 4 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Predictive factors for urogenital injuries (time frame: 5 years). 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 12 Oct 2021.