PolytraumaSteroPolyNCT05794256
Genderspecific Differences in Hormone Levels After Trauma
An observational study of Polytrauma, run by Technical University of Munich at 1 site in Germany.
Trial summary
The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 18 Mar 2023to 1 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients suffering from severe trauma (ISS ≥ 16) or severe traumatic brain injury (AIS ≥3) will be enrolled in this study.
Who may be able to join
- Polytrauma with ISS≥16,
- severe traumatic brain injury (AIS ≥3)
- over the age of 18
- must reach emergency room alive
Who cannot join
- pregnant patients
- dead on arrival to the hospital
- incarcerated patients
- secondarily transferred patients
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Technical University Munich
München, Bavaria, 81675
Peter Biberthaler, Prof., +498941402126
About this study
Official title: A Prospective Analysis of the Gender Specific Role of Steroid Hormones on the Outcome on Patients After Polytrauma
The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma.
This is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status.
Hormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. Furthermore a detailed questionnaire aims to answer any hormone-related health questions.
- Conditions
- Polytrauma
- Being tested
- No interventions are planned
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions are plannedOther
No interventions are planned
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: within 1 year after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start18 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT05794256
- Sponsor's protocol ID
- 2022-687-S-SR
- Acronym
- SteroPoly
- Status last verified
- Nov 2022
- First submitted
- 20 Mar 2023
- Last updated
- 3 Apr 2023
- 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of the Gender Specific Role of Steroid Hormones on the Outcome on Patients After Polytrauma
- ClinicalTrials.gov ID
- NCT05794256
- Acronym / sponsor ID
- SteroPoly / 2022-687-S-SR
- Conditions
- Polytrauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 3 Apr 2023 (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.
The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma.
This is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status.
Hormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. Furthermore a detailed questionnaire aims to answer any hormone-related health questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients suffering from severe trauma (ISS ≥ 16) or severe traumatic brain injury (AIS ≥3) will be enrolled in this study.
Key inclusion criteria (4 listed)
- Polytrauma with ISS≥16,
- severe traumatic brain injury (AIS ≥3)
- over the age of 18
- must reach emergency room alive
Key exclusion criteria (4 listed)
- pregnant patients
- dead on arrival to the hospital
- incarcerated patients
- secondarily transferred patients
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 |
|---|---|---|
| No interventions are plannedNo interventions are planned | Other | – |
Primary outcome
Mortality
Time frame: within 1 year after trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- 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.
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, run by Technical University of Munich at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. 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 Germany. 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?
Contact Olivia Mair, MD (+498941409382, oliviaanna.mair@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: within 1 year after trauma). 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 3 Apr 2023.