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Inflammatory Response After Muscle and Skeleton Trauma

NCT ID: NCT00710411

Last Updated: 2015-12-17

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

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to determine the inflammatory response after multiple trauma in humans.

Detailed Description

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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

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Multiple Trauma

Keywords

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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 shock organ dysfunctions SOFA severity of disease APACHEII SAPSII SPAPS3 length of stay wound healing outcome mortality

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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A, 2

Polytraumatized patients with ISS \> 18 and healthy controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* multiple trauma injury, injury severity score (ISS) \> 18 with

1. isolated fractures of the extremities
2. fractures of the extremities combined with blunt/penetrating visceral trauma
3. fractures of the extremities combined with blunt/penetrating thoracic trauma
4. isolated head injury with morphological changes in CCT
5. combination of points 1 - 4

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Manfred Weiss

Professor, MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manfred M Weiss, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

Locations

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Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 22244896 (View on PubMed)

Unnewehr 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.

Reference Type RESULT
PMID: 23479227 (View on PubMed)

Denk 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.

Reference Type RESULT
PMID: 26556956 (View on PubMed)

Kozarcanin 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.

Reference Type RESULT
PMID: 26614707 (View on PubMed)

Other Identifiers

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DFG KFO-200

Identifier Type: -

Identifier Source: org_study_id