Inflammatory Response After Muscle and Skeleton Trauma

Completed

• Conditions: Multiple Trauma

• Registration Number: NCT00710411
• Lead Sponsor: University of Ulm

Brief Summary

The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

Detailed Description

Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS\>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.

Study Timeline

• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-04
• Study Start: 2009-04
• Primary Completion: 2015-10
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• multiple trauma injury, injury severity score (ISS) > 18 with

  1. isolated fractures of the extremities
  2. fractures of the extremities combined with blunt/penetrating visceral trauma
  3. fractures of the extremities combined with blunt/penetrating thoracic trauma
  4. isolated head injury with morphological changes in CCT
  5. combination of points 1 - 4

Exclusion Criteria

• life expectancy < 24 hours
• participation in other trials
• ISS < 18
• cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
• age < 18 years
• known or suspected pregnancy
• patients with ray-treatment or chemotherapy within the last three months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes	0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma

Secondary Outcome Measures

Name	Time	Method
inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality	0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge

Trial Locations

Locations (1)

Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery; 🇩🇪 Ulm, Germany