Inflammatory Response After Muscle and Skeleton Trauma

NCT00710411 | Completed

• 1 other identifier: DFG KFO-200
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

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

  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

Study Arms (1)

A, 2

Polytraumatized patients with ISS \> 18 and healthy controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Polytraumatized patients with an ISS \> 18 Controls: healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead
• German Research Foundation: collaborator

Study Sites (1)

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

Ulm, 89070, Germany

Location

Related Publications (4)

• 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.

  PMID: 22244896 RESULT

• 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.

  PMID: 23479227 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.

  PMID: 26556956 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.

  PMID: 26614707 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, white cells, and tissues will be retained.

MeSH Terms

Conditions

Multiple Trauma; Inflammation; Infections; Systemic Inflammatory Response Syndrome; Sepsis; Shock

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred M Weiss, MD, MBA

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, MBA

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: April 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

DE (1)