NCT05794256

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 3, 2023

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

March 20, 2023

Last Update Submit

March 20, 2023

Conditions

Polytrauma

Outcome Measures

Primary Outcomes (1)

  • Mortality

    within 1 year after trauma

Interventions

No interventions are plannedOTHER

No interventions are planned

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University Munich

München, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Olivia Mair, MD

CONTACT

+498941409382oliviaanna.mair@mri.tum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

March 18, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

April 3, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)