Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation

NCT ID: NCT06758427

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

At least ten percent of trauma patients suffer from any sort of complication. The study aims to identify a risk factor profile to early identify trauma patients at risk.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Trauma patients suffer from a high risk of complications that ranges from soft tissue complications, surgical site infection till bone non-union. Comorbidities are often know to be associated with complications. Also certain blood markers could be identified to be an indicator.

However, certain risk factors have only been investigated in small trauma cohorts so far. This study is a prospective multi center cohort trail that aims to collect all clinical data, comorbidities, medication, blood markers in trauma patients after long bone fractures. In a 6 months and one year follow up patients with complications will be identified. Methods of machine learning will help to identify a risk factor profile for certain groups of patients with complications.

The aim of the study is to early identify patients at risk for a complication after trauma according to their blood marker, clinical, comorbidity and medication profile.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Complications Surgical Site Infection Wound Infection Non-healing Wound Pseudarthrosis Bone Infection Pneumonia Nosocomial Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* acute long bone fracture (humerus, ulna, radius, femur, tibia) with surgical treatment

Exclusion Criteria

* associated severe injury (ISS \> 16)
* associated traumatic brain injury
* associated traumatic spine injury
* dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BG Klinik Murnau

UNKNOWN

Sponsor Role collaborator

BG Trauma Center Ludwigshafen

OTHER

Sponsor Role collaborator

BG Klinikum Duisburg

UNKNOWN

Sponsor Role collaborator

BG Klink Hamburg

UNKNOWN

Sponsor Role collaborator

Unfallkrankenhaus Berlin

OTHER

Sponsor Role collaborator

BG Ambulanz Bremen

UNKNOWN

Sponsor Role collaborator

Bundeswehrkrankenhaus Ulm

UNKNOWN

Sponsor Role collaborator

Paracelsus Universität Salzburg

UNKNOWN

Sponsor Role collaborator

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marie K Reumann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie K Reumann, MD

Role: CONTACT

+497071606 ext. 3113

Mika Rollmann, MD

Role: CONTACT

+497071606 ext. 3002

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HELICOPTER

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bone Healing Study
NCT03244969 WITHDRAWN
Pre-hospital Tourniquet in Extremity Injury
NCT04216225 ENROLLING_BY_INVITATION