NCT02682550

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

4 years

First QC Date

January 19, 2016

Last Update Submit

February 10, 2016

Conditions

Multiple Trauma

Keywords

polytraumahemorrhagic shocksepsisMODS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (13)

  • Multiple-Organ-Failure (MOF)

    0-28 days after trauma

  • Sepsis

    0-28 days after trauma

  • S100 calcium-binding protein B plasma concentration

    within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma

  • Creatinine plasma concentration

    within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma

  • Bilirubin plasma concentration

    within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma

  • +8 more secondary outcomes

Study Arms (2)

Ctrl

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

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

Procedure: blood drawing

Interventions

blood drawingPROCEDURE

blood drawing

CtrlPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • age ≥ 18
  • healthy

You may not qualify if:

  • age \< 18
  • gravidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32983160DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-Plasma and Serum (drawn from polytrauma patients with an injury severity score ≥25)

MeSH Terms

Conditions

Multiple TraumaShock, HemorrhagicSepsisMultiple Organ Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and InjuriesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShockInfectionsSystemic Inflammatory Response SyndromeInflammation

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Markus Huber-Lang, M.D. Prof

    University of Ulm, Center for Biomedical Research (ZBF)

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

#49-731-5000markus.huber-lang@uniklinik-ulm.de

Manfred Weiss, M.D., Prof.

CONTACT

#49-731-5000manfred.weiss@uniklinik-ulm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Professor for Clinical and Experimental Trauma-Immunology

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 15, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

February 15, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)