Inflammatory Response After Muscle and Skeleton Trauma
Information source: University of Ulm
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Trauma
Phase: N/A
Status: Recruiting
Sponsored by: University of Ulm Official(s) and/or principal investigator(s):
Manfred M Weiss, MD, MBA, Principal Investigator, Affiliation: Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
Overall contact:
Manfred M Weiss, MD, MBA, Phone: +49 - (0)731-500-60226, Email: manfred.weiss@uniklinik-ulm.de
Summary
The purpose of this study is to determine the inflammatory response after multiple trauma in
humans.
Clinical Details
Official title: Inflammatory Response in Polytraumatized Patients
Study design: Case Control, Prospective
Primary outcome: Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes
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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Manfred M Weiss, MD, MBA, Phone: +49 - (0)731-500-60226, Email: manfred.weiss@uniklinik-ulm.de
Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery, Ulm 89070, Germany; Recruiting
Manfred M Weiss, MD, MBA, Phone: +49-(0)731-500-60226, Email: manfred.weiss@uniklinik-ulm.de
Markus M Huber-Lang, MD, Phone: +49-(0)731-500-54569, Email: markus.huber-lang@uniklinik-ulm.de
Markus M Huber-Lang, MD, Principal Investigator
Marion M Schneider, PhD, Sub-Investigator
Florian F Gebhard, MD, Sub-Investigator
Michael M Georgieff, MD, Sub-Investigator
Heidemarie H Suger-Wiedeck, MD, Sub-Investigator
Karl K Traeger, MD, Sub-Investigator
Uwe U Senftleben, MD, Sub-Investigator
Florian F Wagner, MD, Sub-Investigator
Miriam M Kalbitz, MD, Sub-Investigator
Mario M Perl, MD, Sub-Investigator
Doris D Henne-Bruns, MD, Sub-Investigator
Ludger L Sunder-Plassmann, MD, Principal Investigator
Dieter D Woischnek, MD, Sub-Investigator
Heiko H Reichel, MD, Sub-Investigator
Rolf R Brenner, MD, Sub-Investigator
Joerg J Fiedler, MD, Sub-Investigator
Barbara B Acker, Sub-Investigator
Additional Information
Starting date: April 2009
Ending date: December 2011
Last updated: April 1, 2009
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