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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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The purpose of this study is to determine the inflammatory response after multiple trauma in humans.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, 2 | Polytraumatized patients with ISS > 18 and healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes | 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
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
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
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Polytraumatized patients with an ISS > 18 Controls: healthy volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Manfred M Weiss, MD, MBA | Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery | Ulm | 89070 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22244896 | Result | 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. | |
| 23479227 | Result |
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| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D007249 | Inflammation |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D018805 | Sepsis |
| D012769 | Shock |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Whole blood, serum, white cells, and tissues will be retained.
| 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. |
| 26556956 | Result | 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. |
| 26614707 | Result | 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. |