Inflammatory Response After Muscle and Skeleton Trauma

Multiple Trauma Clinical Trial

— IRAMST  

Official title:

Inflammatory Response in Polytraumatized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710411
• Other study ID #: DFG KFO-200
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: December 16, 2015
• Start date: April 2009
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Trauma

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Denk S, Wiegner R, Hönes FM, Messerer DA, Radermacher P, Weiss M, Kalbitz M, Ehrnthaller C, Braumüller 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 Cl — View Citation

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/ — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No