Genderspecific Differences in Hormone Levels After Trauma (SteroPoly)

March 20, 2023 updated by: Technical University of Munich

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Recruiting
        • Technical University Munich
        • Contact:
          • Peter Biberthaler, Prof.
          • Phone Number: +498941402126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: within 1 year after trauma
within 1 year after trauma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-687-S-SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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