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

Not yet recruiting

• Conditions: Postoperative Complications; Surgical Site Infection; Wound Infection; Non-healing Wound; Pseudarthrosis; Bone Infection; Pneumonia; Nosocomial Infection

• Registration Number: NCT06758427
• Lead Sponsor: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu

Brief Summary

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

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2024-12-27
• Last Update Submitted: 2024-12-27
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Study Start: 2025-02-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

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

Read More

Exclusion Criteria

• associated severe injury (ISS > 16)
• associated traumatic brain injury
• associated traumatic spine injury
• dementia

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
any complication after long bone fracture	6 months, one year	number of patients that suffer from a complication after surgical treatment of a primary long bone fracture
Clavien Dindo Classification	6 months, one year	Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.

Secondary Outcome Measures

Name	Time	Method
Charlson Comorbidity Index (CCI)	Initially	Charlson Comorbidity Index classifies comorbidities of patients. All particiapants will be screened for their comorbidities and classified according to CCI.
number of medications	initally	Intake of medication will be assessed and number of medication will be identified.
EuroQual 5 Dimensions Questionnaire (EQ5D5L)	initially, 6 months, one year.	EQ5D5L will be assessed from each participant to identify their quality of life.
patient reported outcome measure associated with the lone bone fracture	initially, 6 months, one year.	patient reported outcome measure will be assessed by each patient that is associated with the lone bone fracture

Trial Locations

Locations (1)

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany