Multiple TraumaNTF-PTNCT02682550
Danger Response in Polytrauma Patients
An observational study of Multiple Trauma, run by University of Ulm at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Trauma
- What is being tested?
- blood drawing
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- age ≥ 18
- healthy
Who cannot join
- age < 18
- gravidity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Ulm, Baden-Wurttemberg, 89081
Markus S Huber-Lang, M.D., Prof., 0049-731-5000 ext. 54717, markus.huber-lang@uniklinik-ulm.de
Manfred Weiss, M.D., Prof., 0049-731-5000 ext. 60226, manfred.weiss@uniklinik-ulm.de
About this study
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)
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.
Read the 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:
- how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers?
- how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level?
- 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
- Multiple Trauma
- Being tested
- blood drawing
- Keywords
- polytrauma, hemorrhagic shock, sepsis, MODS
- Medical subject headings
- Multiple Trauma, Shock, Hemorrhagic, Sepsis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawingProcedure or surgery
blood drawing
| Study group | Role | What they receive |
|---|---|---|
| Ctrl | healthy volunteers, sex- and age matched Blood drawing at one time point: 20 ml Receives: 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 Receives: Procedure: blood drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6) plasma concentration
Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma
Measured: 24 hours after polytrauma
Secondary outcomes (13)
Multiple-Organ-Failure (MOF)
daily "Sequential Organ Failure Assessment" score
Measured: 0-28 days after trauma
Sepsis
sepsis definition daily in accordance to the "American College of Chest Physicians/Society of Critical Care Medicine" Consensus
Measured: 0-28 days after trauma
S100 calcium-binding protein B plasma concentration
plasma S100 calcium-binding protein B as a marker for central nervous system injury
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Creatinine plasma concentration
plasma creatinine to measure the glomerular filtration rate as a marker of renal function.
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Bilirubin plasma concentration
plasma bilirubin as a biomarker for liver failure
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Survival
survival recorded every day: yes/no
Measured: 28-day survival
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
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
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
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-10
Inflammatory profiling: plasma concentrations of Interleukin-10
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-1beta
Inflammatory profiling: plasma concentrations of Interleukin-1beta
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Complement factor C3a
Inflammatory profiling: plasma concentrations of Complement factor C3a
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Arterial partial oxygen pressure
Arterial partial oxygen pressure reflects lung performance
Measured: daily, the first 10 days after trauma
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
Measured: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Huber-Lang, University of Ulm
- Investigators
- Markus Huber-Lang, M.D. Prof, Study director, University of Ulm, Center for Biomedical Research (ZBF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682550
- Sponsor's protocol ID
- NTF_PT_2014
- Acronym
- NTF-PT
- Status last verified
- Feb 2016
- First submitted
- 19 Jan 2016
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Karasu E, Halbgebauer R, Schutte L, Greven J, Blasius FM, Zeller J, Winninger O, Braig D, Messerer DAC, Berger B, Feuerstein H, Schultze A, Peter K, Knippschild U, Horst K, Hildebrand F, Eisenhardt SU, Huber-Lang M. A conformational change of C-reactive protein drives neutrophil extracellular trap formation in inflammation. BMC Biol. 2025 Jan 7;23(1):4. doi: 10.1186/s12915-024-02093-8.
PubMed 39773175Halbgebauer 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.
PubMed 32983160
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02682550
- Acronym / sponsor ID
- NTF-PT / NTF_PT_2014
- Conditions
- Multiple Trauma
- Keywords
- polytrauma, hemorrhagic shock, sepsis, MODS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers?
- how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ctrl | – | Procedure: blood drawinghealthy volunteers, sex- and age matched Blood drawing at one time point: 20 ml |
| PT | – | Procedure: blood drawingpolytrauma 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- age ≥ 18
- healthy
Key exclusion criteria (2 listed)
- age < 18
- gravidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawingblood drawing | Procedure or surgery | Ctrl, PT |
Primary outcome
Interleukin-6 (IL-6) plasma concentration
Time frame: 24 hours after polytrauma
Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma
13 secondary outcomes
Multiple-Organ-Failure (MOF)
Time frame: 0-28 days after trauma
Sepsis
Time frame: 0-28 days after trauma
S100 calcium-binding protein B plasma concentration
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Creatinine plasma concentration
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Bilirubin plasma concentration
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Survival
Time frame: 28-day survival
monomeric C-reactive protein
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
pentameric C-reactive protein
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-10
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Interleukin-1beta
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Complement factor C3a
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Arterial partial oxygen pressure
Time frame: daily, the first 10 days after trauma
Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry)
Time frame: within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Derived from this study: PubMed 39773175Karasu E, Halbgebauer R, Schutte L, Greven J, Blasius FM, Zeller J, Winninger O, Braig D, Messerer DAC, Berger B, Feuerstein H, Schultze A, Peter K, Knippschild U, Horst K, Hildebrand F, Eisenhardt SU, Huber-Lang M. A conformational change of C-reactive protein drives neutrophil extracellular trap formation in inflammation. BMC Biol. 2025 Jan 7;23(1):4. doi: 10.1186/s12915-024-02093-8.
- Derived from this study: PubMed 32983160Halbgebauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Huber-Lang, M.D. Prof study director
University of Ulm, Center for Biomedical Research (ZBF)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus S Huber-Lang, M.D., Prof. (#49-731-5000 ext. 54717, markus.huber-lang@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) plasma concentration (time frame: 24 hours after polytrauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.