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RecruitingNCT05794256SteroPolyUpdated Apr 3, 2023

Genderspecific Differences in Hormone Levels After Trauma

An observational study in Polytrauma, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Technical University of Munich · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Polytrauma

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03

In context

Multiple Trauma

139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 84 observational studies indexed under Multiple Trauma.

Browse Multiple Trauma studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.

Browse Technical University of Munich studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients suffering from severe trauma (ISS ≥ 16) or severe traumatic brain injury (AIS ≥3) will be enrolled in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Polytrauma with ISS≥16,
  • severe traumatic brain injury (AIS ≥3)
  • over the age of 18
  • must reach emergency room alive

Exclusion criteria

Exclusion Criteria:

  • pregnant patients
  • dead on arrival to the hospital
  • incarcerated patients
  • secondarily transferred patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherNo interventions are planned

    No interventions are planned

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: within 1 year after trauma

07

Study locations

1 of 1 sites recruiting
  • Technical University Munich
    München, Bavaria 81675, Germany
    Recruiting
    • Peter Biberthaler, Prof. · Contact+498941402126
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Jan 2025, 21 months after the start.

Of 30 observational studies under Multiple Trauma, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's planned 21 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2023
First posted
Apr 3, 2023
StartActual
Mar 18, 2023
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jan 1, 2026
Last update
Apr 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05794256
Lead sponsor
Technical University of Munich
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
Mar 18, 2023
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Apr 3, 2023

Study contacts

Olivia Mair, MD
Contact
oliviaanna.mair@mri.tum.de
+498941409382

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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