Multiple TraumaIRAMSTNCT00710411
Inflammatory Response After Muscle and Skeleton Trauma
An observational study of Multiple Trauma, run by University of Ulm at 1 site in Germany.
Trial summary
The purpose of this study is to determine the inflammatory response after multiple trauma in humans. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Trauma
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Dec 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Polytraumatized patients with an ISS > 18 Controls: healthy volunteers
Who may be able to join
- multiple trauma injury, injury severity score (ISS) > 18 with
- isolated fractures of the extremities
- fractures of the extremities combined with blunt/penetrating visceral trauma
- fractures of the extremities combined with blunt/penetrating thoracic trauma
- isolated head injury with morphological changes in CCT
- combination of points 1 - 4
Who cannot join
- life expectancy < 24 hours
- participation in other trials
- ISS < 18
- cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
- age < 18 years
- known or suspected pregnancy
- patients with ray-treatment or chemotherapy within the last three months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery
Ulm, 89070
About this study
Official title: Inflammatory Response in Polytraumatized Patients
The purpose of this study is to determine the inflammatory response after multiple trauma in humans.
Read the detailed description
Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.
- Conditions
- Multiple Trauma
- Keywords
- humans, patients, polytrauma, complement, inflammation, inflammatory response, biomarkers, cytokines, cell surface markers, apoptosis, NF-kappaB, functional polymorphisms, mesenchymal stem cell, severity of injury, ISS, infections, systemic inflammatory response syndrome, SIRS, sepsis, severe sepsis
- Medical subject headings
- Multiple Trauma, Inflammation, Infections, Systemic Inflammatory Response Syndrome, Sepsis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A, 2 | Polytraumatized patients with ISS > 18 and healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes
Measured: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma
Secondary outcomes (1)
inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality
Measured: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startApr 2009
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Manfred M Weiss, MD, MBA, Principal investigator, Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710411
- Sponsor's protocol ID
- DFG KFO-200
- Acronym
- IRAMST
- Status last verified
- Dec 2015
- First submitted
- 2 Jul 2008
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Huber-Lang M, Denk S, Fulda S, Erler E, Kalbitz M, Weckbach S, Schneider EM, Weiss M, Kanse SM, Perl M. Cathepsin D is released after severe tissue trauma in vivo and is capable of generating C5a in vitro. Mol Immunol. 2012 Feb;50(1-2):60-5. doi: 10.1016/j.molimm.2011.12.005. Epub 2012 Jan 14.
PubMed 22244896Unnewehr H, Rittirsch D, Sarma JV, Zetoune F, Flierl MA, Perl M, Denk S, Weiss M, Schneider ME, Monk PN, Neff T, Mihlan M, Barth H, Gebhard F, Ward PA, Huber-Lang M. Changes and regulation of the C5a receptor on neutrophils during septic shock in humans. J Immunol. 2013 Apr 15;190(8):4215-25. doi: 10.4049/jimmunol.1200534. Epub 2013 Mar 11.
PubMed 23479227Denk S, Wiegner R, Hones FM, Messerer DA, Radermacher P, Weiss M, Kalbitz M, Ehrnthaller C, Braumuller S, McCook O, Gebhard F, Weckbach S, Huber-Lang M. Early Detection of Junctional Adhesion Molecule-1 (JAM-1) in the Circulation after Experimental and Clinical Polytrauma. Mediators Inflamm. 2015;2015:463950. doi: 10.1155/2015/463950. Epub 2015 Oct 18.
PubMed 26556956Kozarcanin H, Lood C, Munthe-Fog L, Sandholm K, Hamad OA, Bengtsson AA, Skjoedt MO, Huber-Lang M, Garred P, Ekdahl KN, Nilsson B. The lectin complement pathway serine proteases (MASPs) represent a possible crossroad between the coagulation and complement systems in thromboinflammation. J Thromb Haemost. 2016 Mar;14(3):531-45. doi: 10.1111/jth.13208. Epub 2016 Feb 15.
PubMed 26614707Karasu 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 39773175
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Response in Polytraumatized Patients
- ClinicalTrials.gov ID
- NCT00710411
- Acronym / sponsor ID
- IRAMST / DFG KFO-200
- Conditions
- Multiple Trauma
- Keywords
- humans, patients, polytrauma, complement, inflammation, inflammatory response, biomarkers, cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Apr 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jul 2008 (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 purpose of this study is to determine the inflammatory response after multiple trauma in humans.
Detailed description
Polytraumatized patients are via a systemic inflammatory response syndrome at high risk for an uneventful outcome in the posttraumatic phase. One of the main functions of the inflammatory response is the recognition and elimination of damaged tissues and microorganisms. In polytraumatized patients, a huge amount of damaged cells occurs which has to be eliminated by programmed cell death (apoptosis)without damaging surrounding tissues. It remains unclear whether, when and how an interplay of complement system, NF-kB, danger and pattern recognition receptors, apoptosis, mesenchymal stem cells and their regulation may be beneficial and harmful. Differing activation of the complement system, pro-inflammatory biomarkers and predisposing polymorphisms of response and receptor genes are expected to lead to varying outcome. Therefore, this prospective observational study will enroll n=60 polytraumatized patients with an ISS>18 to monitor longitudinally their inflammatory response after trauma and to find out whether there is a discriminating pattern of the cross talk between complement system, biomarkers and apoptosis in patients with beneficial or harmful outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, 2 | – | –Polytraumatized patients with ISS > 18 and healthy controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Polytraumatized patients with an ISS > 18 Controls: healthy volunteers
Key inclusion criteria (6 listed)
- multiple trauma injury, injury severity score (ISS) > 18 with
Key exclusion criteria (7 listed)
- life expectancy < 24 hours
- participation in other trials
- ISS < 18
- cardiopulmonary reanimation on the accident scene or dying immediately after hospital admission
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes
Time frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma
1 secondary outcome
inflammatory biomarkers, cell surface markers, apoptosis, functional polymorphisms, mesenchymal stem cells, severity of injury (ISS), infections, SIRS, sepsis, shock, organ dysfunctions, severity of disease, ICU length of stay, wound healing, mortality
Time frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma for biochemical and immunological parameters; ISS on admission; scores on a daily basis; ICU and hospital death on discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Results publication: PubMed 22244896Huber-Lang M, Denk S, Fulda S, Erler E, Kalbitz M, Weckbach S, Schneider EM, Weiss M, Kanse SM, Perl M. Cathepsin D is released after severe tissue trauma in vivo and is capable of generating C5a in vitro. Mol Immunol. 2012 Feb;50(1-2):60-5. doi: 10.1016/j.molimm.2011.12.005. Epub 2012 Jan 14.
- Results publication: PubMed 23479227Unnewehr H, Rittirsch D, Sarma JV, Zetoune F, Flierl MA, Perl M, Denk S, Weiss M, Schneider ME, Monk PN, Neff T, Mihlan M, Barth H, Gebhard F, Ward PA, Huber-Lang M. Changes and regulation of the C5a receptor on neutrophils during septic shock in humans. J Immunol. 2013 Apr 15;190(8):4215-25. doi: 10.4049/jimmunol.1200534. Epub 2013 Mar 11.
- Results publication: PubMed 26556956Denk S, Wiegner R, Hones FM, Messerer DA, Radermacher P, Weiss M, Kalbitz M, Ehrnthaller C, Braumuller S, McCook O, Gebhard F, Weckbach S, Huber-Lang M. Early Detection of Junctional Adhesion Molecule-1 (JAM-1) in the Circulation after Experimental and Clinical Polytrauma. Mediators Inflamm. 2015;2015:463950. doi: 10.1155/2015/463950. Epub 2015 Oct 18.
- Results publication: PubMed 26614707Kozarcanin H, Lood C, Munthe-Fog L, Sandholm K, Hamad OA, Bengtsson AA, Skjoedt MO, Huber-Lang M, Garred P, Ekdahl KN, Nilsson B. The lectin complement pathway serine proteases (MASPs) represent a possible crossroad between the coagulation and complement systems in thromboinflammation. J Thromb Haemost. 2016 Mar;14(3):531-45. doi: 10.1111/jth.13208. Epub 2016 Feb 15.
- 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.
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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.
Manfred M Weiss, MD, MBA principal investigator
Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes (time frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma). 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 NCT00710411, which also lists 5 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 17 Dec 2015.