The NTF\_PT\_2014 multicenter study aims to collect, store, and analyse plasma and serum from polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic response and regenerative potential on an organ-, cell, and molecular level, and 3) how could a specific organ- and immune-monitoring predict the clinical outcome.
Polytrauma is worldwide a major socio-economic problem. Especially the polytrauma-induced complications, such as systemic inflammatory response, sepsis, organ dysfunction remain associated with a high morbidity and mortality rate. The underlying posttraumatic pathophysiology remains poorly understood, especially since the polytrauma patients present a highly variable patient cohort with complex injury patterns, comorbidities and different therapeutic strategies. Therefore, the present "NTF\_PT\_2014" multicenter study of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU) with its established national Polytrauma-serum-bank aims to collect, store, and analyse plasma and serum from polytrauma-patients and corresponding clinical data to address: 1. how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers? 2. how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level? 3. how could a specific organ- and immune-monitoring predict the clinical outcome? Blood will be drawn from anticipated 1000 patients with an injury severity score ≥ 25 at the time of hospital admission (in the emergency room), 8 h, 24h, 48, 120 h, and 240 h post injury. The biochemical and immune-monitoring data will be correlated to corresponding clinical data and data from the German Trauma Registry (TraumaRegister DGU®). Blood from age- and sex matched healthy volunteers (n=200) will serve as a control group. The study will provide a detailed picture of the molecular danger response after multiple injury and may reveal novel therapeutic targets for posttraumatic complications.
Study Type
OBSERVATIONAL
Enrollment
1,000
blood drawing
University Hospital
Ulm, Baden-Wurttemberg, Germany
RECRUITINGInterleukin-6 (IL-6) plasma concentration
Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma
Time frame: 24 hours after polytrauma
Multiple-Organ-Failure (MOF)
daily "Sequential Organ Failure Assessment" score
Time frame: 0-28 days after trauma
Sepsis
sepsis definition daily in accordance to the "American College of Chest Physicians/Society of Critical Care Medicine" Consensus
Time frame: 0-28 days after trauma
S100 calcium-binding protein B plasma concentration
plasma S100 calcium-binding protein B as a marker for central nervous system injury
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Creatinine plasma concentration
plasma creatinine to measure the glomerular filtration rate as a marker of renal function.
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Bilirubin plasma concentration
plasma bilirubin as a biomarker for liver failure
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Survival
survival recorded every day: yes/no
Time frame: 28-day survival
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monomeric C-reactive protein
C-reactive protein may not only represent a biomarker of the systemic inflammatory response after trauma but also help to clear danger- and pathogen-associated molecular patterns
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
pentameric C-reactive protein
C-reactive protein may not only represent a biomarker of the systemic inflammatory response after trauma but also help to clear danger- and pathogen-associated molecular patterns
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-10
Inflammatory profiling: plasma concentrations of Interleukin-10
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-1beta
Inflammatory profiling: plasma concentrations of Interleukin-1beta
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Complement factor C3a
Inflammatory profiling: plasma concentrations of Complement factor C3a
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Arterial partial oxygen pressure
Arterial partial oxygen pressure reflects lung performance
Time frame: daily, the first 10 days after trauma
Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry)
Microvesicles as carriers of clotting factors and inflammatory molecules may be significantly involved in the coagulatory and inflammatory response after trauma
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma