Inflammatory Response After Muscle and Skeleton Trauma (IRAMST)

University of Ulm

Status: Completed

Conditions: Multiple Trauma

Study type: Observational

Funder types: Other

Identifiers

NCT00710411

DFG KFO-200

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

48 participants in 1 patient group

A, 2

Description:

Polytraumatized patients with ISS \> 18 and healthy controls