Hierarchy of Effects of Laboratory Markers and Their Interaction With Comorbidity Concerning Outcome and Personalized Treatment of Trauma Patients in Emergency Care and Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Complications, Surgical Site Infection, Wound Infection, Non-healing Wound. Basic parameters: 18 years — 67 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- any complication after long bone fracture [Time frame: 6 months, one year]
- Clavien Dindo Classification [Time frame: 6 months, one year]
Secondary outcome measures (4)
- Charlson Comorbidity Index (CCI) [Time frame: Initially]
- number of medications [Time frame: initally]
- EuroQual 5 Dimensions Questionnaire (EQ5D5L) [Time frame: initially, 6 months, one year.]
- patient reported outcome measure associated with the lone bone fracture [Time frame: initially, 6 months, one year.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen — Tübingen
Identifiers
NCT: NCT06758427 · HELICOPTER