Multiple Trauma
Conditions
Keywords
polytrauma, hemorrhagic shock, sepsis, MODS
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREblood drawing
blood drawing
Sponsors
University of Ulm
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age ≥ 18 * healthy
Exclusion criteria
* age \< 18 * gravidity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) plasma concentration | 24 hours after polytrauma | Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis | 0-28 days after trauma | sepsis definition daily in accordance to the American College of Chest Physicians/Society of Critical Care Medicine Consensus |
| S100 calcium-binding protein B plasma concentration | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | plasma S100 calcium-binding protein B as a marker for central nervous system injury |
| Creatinine plasma concentration | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | plasma creatinine to measure the glomerular filtration rate as a marker of renal function. |
| Bilirubin plasma concentration | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | plasma bilirubin as a biomarker for liver failure |
| Survival | 28-day survival | survival recorded every day: yes/no |
| monomeric C-reactive protein | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | 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 |
| Multiple-Organ-Failure (MOF) | 0-28 days after trauma | daily Sequential Organ Failure Assessment score |
| Interleukin-10 | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | Inflammatory profiling: plasma concentrations of Interleukin-10 |
| Interleukin-1beta | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | Inflammatory profiling: plasma concentrations of Interleukin-1beta |
| Complement factor C3a | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | Inflammatory profiling: plasma concentrations of Complement factor C3a |
| Arterial partial oxygen pressure | daily, the first 10 days after trauma | Arterial partial oxygen pressure reflects lung performance |
| Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry) | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | Microvesicles as carriers of clotting factors and inflammatory molecules may be significantly involved in the coagulatory and inflammatory response after trauma |
| pentameric C-reactive protein | within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma | 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 |
Countries
Germany
Contacts
Primary ContactMarkus S Huber-Lang, M.D., Prof.
Backup ContactManfred Weiss, M.D., Prof.
Outcome results
None listed