Clinical trial NCT06758427: Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
Official title: Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Complications
Surgical Site Infection
Wound Infection
Non-healing Wound
Pseudarthrosis
Bone Infection
Pneumonia
Nosocomial Infection
Keywords: long bone fracture, trauma
Lead sponsor: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu
Sponsor class: OTHER
Collaborators: name: BG Klinik Murnau
name: BG Trauma Center Ludwigshafen
name: BG Klinikum Duisburg
name: BG Klink Hamburg
name: Unfallkrankenhaus Berlin
name: BG Ambulanz Bremen
name: Bundeswehrkrankenhaus Ulm
name: Paracelsus Universität Salzburg
First posted: 2025-01-03
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients that suffer from an acute lone bone fracture, require surgical treatment and belong to the age group of being able to working (18 - 67 years old)

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.

Eligibility criteria: 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

Primary outcomes:
measure: any complication after long bone fracture
timeFrame: 6 months, one year
measure: Clavien Dindo Classification
timeFrame: 6 months, one year
Secondary outcomes:
measure: Charlson Comorbidity Index (CCI)
timeFrame: Initially
measure: number of medications
timeFrame: initally
measure: EuroQual 5 Dimensions Questionnaire (EQ5D5L)
timeFrame: initially, 6 months, one year.
measure: patient reported outcome measure associated with the lone bone fracture
timeFrame: initially, 6 months, one year.
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen
name: Marie K Reumann, MD
role: PRINCIPAL_INVESTIGATOR
References: