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Danger Response in Polytrauma Patients (NTF-PT)

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ClinicalTrials.gov Identifier: NCT02682550
Recruitment Status : Unknown
Verified February 2016 by Markus Huber-Lang, University of Ulm.
Recruitment status was:  Recruiting
First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Markus Huber-Lang, University of Ulm

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.

Condition or disease Intervention/treatment
Multiple Trauma Procedure: blood drawing

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Danger Response After Polytrauma Based on the National Polytrauma-serum-bank of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU)
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ctrl
healthy volunteers, sex- and age matched Blood drawing at one time point: 20 ml
Procedure: blood drawing
blood drawing

PT

polytrauma patients fulfilling the following criteria:

  • injury severity score ≥25
  • age ≥ 18 Blood drawing at admission to the emergency room, 8 h, 24h, 48 h, 120 h and 240 h post trauma: 20 ml
Procedure: blood drawing
blood drawing




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Multiple-Organ-Failure (MOF) [ Time Frame: 0-28 days after trauma ]
    daily "Sequential Organ Failure Assessment" score

  2. 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

  3. 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

  4. 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.

  5. 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

  6. Survival [ Time Frame: 28-day survival ]
    survival recorded every day: yes/no

  7. 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

  8. 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

  9. 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

  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

  11. 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

  12. Arterial partial oxygen pressure [ Time Frame: daily, the first 10 days after trauma ]
    Arterial partial oxygen pressure reflects lung performance

  13. 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


Biospecimen Retention:   Samples With DNA
EDTA-Plasma and Serum (drawn from polytrauma patients with an injury severity score ≥25)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

polytrauma patients age ≥ 18 ISS ≥ 25

Exclusion: cardiopulmonary reanimation before admission, gravidity, no chemotherapy or radiotherapy within the last 3 months, immune supressive drugs, hemodialysis, age < 18

Criteria

Inclusion Criteria:

  • age ≥ 18
  • healthy

Exclusion Criteria:

  • age < 18
  • gravidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682550


Contacts
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Contact: Markus S Huber-Lang, M.D., Prof. #49-731-5000 ext 54717 markus.huber-lang@uniklinik-ulm.de
Contact: Manfred Weiss, M.D., Prof. #49-731-5000 ext 60226 manfred.weiss@uniklinik-ulm.de

Locations
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Germany
University Hospital Recruiting
Ulm, Baden-Wuerttemberg, Germany, 89081
Contact: Markus S Huber-Lang, M.D., Prof.    0049-731-5000 ext 54717    markus.huber-lang@uniklinik-ulm.de   
Contact: Manfred Weiss, M.D., Prof.    0049-731-5000 ext 60226    manfred.weiss@uniklinik-ulm.de   
Principal Investigator: Mario Perl, M.D., Prof.         
Sub-Investigator: Ingo Marzi, M.D., Prof.         
Sub-Investigator: Martijn Van Griensven, M.D., Prof.         
Sub-Investigator: Roman Pfeiffer, M.D.         
Sponsors and Collaborators
University of Ulm
Investigators
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Study Director: Markus Huber-Lang, M.D. Prof University of Ulm, Center for Biomedical Research (ZBF)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Markus Huber-Lang, M.D., Professor for Clinical and Experimental Trauma-Immunology, University of Ulm
ClinicalTrials.gov Identifier: NCT02682550    
Other Study ID Numbers: NTF_PT_2014
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Markus Huber-Lang, University of Ulm:
polytrauma
hemorrhagic shock
sepsis
MODS
Additional relevant MeSH terms:
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Multiple Trauma
Wounds and Injuries