Inflammatory Response After Muscle and Skeleton Trauma

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

Detailed Description
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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.

Official Title
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Inflammatory Response in Polytraumatized Patients

Conditions
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Multiple Trauma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: multiple trauma injury, injury severity score (ISS) > 18 with isolated fractures of the extremities fractures of the extremities combined with blunt/penetrating visceral trauma fractures of the extremities combined with blunt/penetrating thoracic trauma isolated head injury with morphological changes in CCT 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A, 2<br>Polytraumatized patients with ISS > 18 and healthy controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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humans, patients, polytrauma, complement, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, apoptosis, NF-kappaB, functional polymorphisms, mesenchymal stem cell, severity of injury, ISS, infections, systemic inflammatory response syndrome, SIRS, sepsis, severe sepsis, shock, organ dysfunctions, SOFA, severity of disease, APACHEII, SAPSII, SPAPS3, length of stay, wound healing, outcome, mortality