Danger Response in Polytrauma Patients

NCT ID: NCT02682550

Last Updated: 2016-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Multiple Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ctrl

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

blood drawing

Intervention Type PROCEDURE

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

blood drawing

Intervention Type PROCEDURE

blood drawing

Interventions

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blood drawing

blood drawing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18
* healthy

Exclusion Criteria

* age \< 18
* gravidity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Markus Huber-Lang

M.D., Professor for Clinical and Experimental Trauma-Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Huber-Lang, M.D. Prof

Role: STUDY_DIRECTOR

University of Ulm, Center for Biomedical Research (ZBF)

Locations

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University Hospital

Ulm, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus S Huber-Lang, M.D., Prof.

Role: CONTACT

#49-731-5000 ext. 54717

Manfred Weiss, M.D., Prof.

Role: CONTACT

#49-731-5000 ext. 60226

Facility Contacts

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Markus S Huber-Lang, M.D., Prof.

Role: primary

0049-731-5000 ext. 54717

Manfred Weiss, M.D., Prof.

Role: backup

0049-731-5000 ext. 60226

References

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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.

Reference Type DERIVED
PMID: 32983160 (View on PubMed)

Other Identifiers

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NTF_PT_2014

Identifier Type: -

Identifier Source: org_study_id

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