Danger Response in Polytrauma Patients

Multiple Trauma Clinical Trial

— NTF-PT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02682550
• Other study ID #: NTF_PT_2014
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2016
• Last updated: February 10, 2016
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: February 2016
• Source: University of Ulm
• Contact: Markus S Huber-Lang, M.D., Prof.
• Phone: #49-731-5000
• Email: markus.huber-lang[@]uniklinik-ulm.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age = 18

• healthy

Exclusion Criteria:

• age < 18

• gravidity

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Trauma

Intervention

Procedure:
• blood drawing
blood drawing

Locations

Country	Name	City	State
Germany	University Hospital	Ulm	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (IL-6) plasma concentration	Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma	24 hours after polytrauma	No
Secondary	Multiple-Organ-Failure (MOF)	daily "Sequential Organ Failure Assessment" score	0-28 days after trauma	No
Secondary	Sepsis	sepsis definition daily in accordance to the "American College of Chest Physicians/Society of Critical Care Medicine" Consensus	0-28 days after trauma	No
Secondary	S100 calcium-binding protein B plasma concentration	plasma S100 calcium-binding protein B as a marker for central nervous system injury	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Creatinine plasma concentration	plasma creatinine to measure the glomerular filtration rate as a marker of renal function.	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Bilirubin plasma concentration	plasma bilirubin as a biomarker for liver failure	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Survival	survival recorded every day: yes/no	28-day survival	No
Secondary	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	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	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	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Interleukin-10	Inflammatory profiling: plasma concentrations of Interleukin-10	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Interleukin-1beta	Inflammatory profiling: plasma concentrations of Interleukin-1beta	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Complement factor C3a	Inflammatory profiling: plasma concentrations of Complement factor C3a	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No
Secondary	Arterial partial oxygen pressure	Arterial partial oxygen pressure reflects lung performance	daily, the first 10 days after trauma	No
Secondary	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	within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma	No