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

NCT06758427 | Not Yet Recruiting DMC

• 1 other identifier: HELICOPTER
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

long bone fracture, trauma

Outcome Measures

Primary Outcomes (2)

• any complication after long bone fracture

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

  6 months, one year

• Clavien Dindo Classification

  Clavien Dindo Classification classifies surgical complications. All patients will be classified according to Clavien Dindo after 6 months and one year.

  6 months, one year

Secondary Outcomes (4)

• Charlson Comorbidity Index (CCI)

  Initially

• number of medications

  initally

• EuroQual 5 Dimensions Questionnaire (EQ5D5L)

  initially, 6 months, one year.

• patient reported outcome measure associated with the lone bone fracture

  initially, 6 months, one year.

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu: lead
• BG Klinik Murnau: collaborator
• BG Trauma Center Ludwigshafen: collaborator
• BG Klinikum Duisburg: collaborator
• BG Klink Hamburg: collaborator
• Unfallkrankenhaus Berlin: collaborator
• BG Ambulanz Bremen: collaborator
• Bundeswehrkrankenhaus Ulm: collaborator
• Paracelsus Universität Salzburg: collaborator

Study Sites (1)

Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Postoperative Complications; Surgical Wound Infection; Wound Infection; Pseudarthrosis; Pneumonia; Cross Infection; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Fractures, Ununited; Fractures, Bone; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes

Study Officials

• Marie K Reumann, MD

  Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie K Reumann, MD

CONTACT

+497071606; mreumann@bgu-tuebingen.de

Mika Rollmann, MD

CONTACT

+497071606; mrollmann@bgu-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)