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NCT Number: 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

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.

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Key information

Conditions

Postoperative Complications Bone Infection Cross Infection Disease Attributes Fractures, Bone Fractures, Ununited Iatrogenic Disease Infections Lung Diseases Non-healing Wound Nosocomial Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pseudarthrosis Respiratory Tract Diseases Respiratory Tract Infections Surgical Site Infection Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. any complication after long bone fracture

    Time frame: 6 months, one year

    number of patients that suffer from a complication after surgical treatment of a primary long bone fracture

  2. Clavien Dindo Classification

    Time frame: 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 outcomes

  1. Charlson Comorbidity Index (CCI)

    Time frame: Initially

    Charlson Comorbidity Index classifies comorbidities of patients. All particiapants will be screened for their comorbidities and classified according to CCI.

  2. number of medications

    Time frame: initally

    Intake of medication will be assessed and number of medication will be identified.

  3. EuroQual 5 Dimensions Questionnaire (EQ5D5L)

    Time frame: initially, 6 months, one year.

    EQ5D5L will be assessed from each participant to identify their quality of life.

  4. patient reported outcome measure associated with the lone bone fracture

    Time frame: initially, 6 months, one year.

    patient reported outcome measure will be assessed by each patient that is associated with the lone bone fracture

Study contacts

Contact information is provided by the study sponsor or research team.

Marie K Reumann, MD

CONTACT

[email protected]

+497071606 ext. 3113

Mika Rollmann, MD

CONTACT

[email protected]

+497071606 ext. 3002

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • BG Ambulanz Bremen
  • BG Klinik Murnau
  • BG Klinikum Duisburg
  • BG Klink Hamburg
  • BG Trauma Center Ludwigshafen
  • Bundeswehrkrankenhaus Ulm
  • Paracelsus Universität Salzburg
  • Unfallkrankenhaus Berlin

Registry information

Acronym: HELICOPTER

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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