Clinical trial NCT02682550: Danger Response in Polytrauma Patients
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Trauma
Keywords: polytrauma
hemorrhagic shock
sepsis
MODS
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18
* healthy

Exclusion Criteria:

* age \< 18
* gravidity

Primary outcomes:
measure: Interleukin-6 (IL-6) plasma concentration
timeFrame: 24 hours after polytrauma
Secondary outcomes:
measure: Multiple-Organ-Failure (MOF)
timeFrame: 0-28 days after trauma
measure: Sepsis
timeFrame: 0-28 days after trauma
measure: S100 calcium-binding protein B plasma concentration
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Creatinine plasma concentration
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Bilirubin plasma concentration
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Survival
timeFrame: 28-day survival
measure: monomeric C-reactive protein
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: pentameric C-reactive protein
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Interleukin-10
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Interleukin-1beta
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Complement factor C3a
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
measure: Arterial partial oxygen pressure
timeFrame: daily, the first 10 days after trauma
measure: Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry)
timeFrame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Hospital
state: Baden-Wuerttemberg
Study officials:
affiliation: University of Ulm, Center for Biomedical Research (ZBF)
name: Markus Huber-Lang, M.D. Prof
role: STUDY_DIRECTOR
References:
citation: Halbgebauer R, Karasu E, Braun CK, Palmer A, Braumuller S, Schultze A, Schafer F, Buckle S, Eigner A, Wachter U, Radermacher P, Resuello RRG, Tuplano JV, Nilsson Ekdahl K, Nilsson B, Armacki M, Kleger A, Seufferlein T, Kalbitz M, Gebhard F, Lambris JD, van Griensven M, Huber-Lang M. Thirty-Eight-Negative Kinase 1 Is a Mediator of Acute Kidney Injury in Experimental and Clinical Traumatic Hemorrhagic Shock. Front Immunol. 2020 Aug 26;11:2081. doi: 10.3389/fimmu.2020.02081. eCollection 2020.