Danger Response in Polytrauma Patients (NTF-PT)

University of Ulm

Status: Unknown

Conditions: Multiple Trauma

Treatments: Procedure: blood drawing

Study type: Observational

Funder types: Other

Identifiers

NCT02682550

NTF_PT_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age ≥ 18
• healthy

Exclusion criteria

• age < 18
• gravidity

Trial design

1,000 participants in 2 patient groups

Ctrl

Description:

healthy volunteers, sex- and age matched Blood drawing at one time point: 20 ml

Treatment:

Procedure: blood drawing

PT

Description:

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

Treatment:

Procedure: blood drawing