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NCT05794256 Clinical Trial

Genderspecific Differences in Hormone Levels After Trauma

Polytrauma Clinical Trial

— SteroPoly  

Official title:
A Prospective Analysis of the Gender Specific Role of Steroid Hormones on the Outcome on Patients After Polytrauma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05794256
Other study ID # 2022-687-S-SR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2023
Est. completion date January 1, 2026

Study information
Verified date November 2022
Source Technical University of Munich
Contact Olivia Mair, MD
Phone +498941409382
Email oliviaanna.mair@mri.tum.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 1, 2026
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Polytrauma with ISS=16, - severe traumatic brain injury (AIS =3) - over the age of 18 - must reach emergency room alive Exclusion Criteria: - pregnant patients - dead on arrival to the hospital - incarcerated patients - secondarily transferred patients

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No interventions are planned
No interventions are planned

Locations
Country Name City State
Germany Technical University Munich München Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality within 1 year after trauma
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