Clinical Trial: Danger Response in Polytrauma Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Analysis of the Danger Response After Polytrauma Based on the National Polytrauma-serum-bank of the Trauma Research Network (NTF) of the Germa

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 Summary:

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
Sponsor: University of Ulm

Current Primary Outcome: Interleukin-6 (IL-6) plasma concentration [ Time Frame: 24 hours after polytrauma ]

Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Multiple-Organ-Failure (MOF) [ Time Frame: 0-28 days after trauma ]
    daily "Sequential Organ Failure Assessment" score
  • Sepsis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28-day survival ]
    survival recorded every day: yes/no
  • monomeric C-reactive protein [ Time Frame: 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
  • pentameric C-reactive protein [ Time Frame: 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
  • Interleukin-10 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University of Ulm

Dates:
Date Received: January 19, 2016
Date Started: September 2014
Date Completion: October 2018
Last Updated: February 10, 2016
Last Verified: February 2016