Inflammatory Response After Muscle and Skeleton Trauma (IRAMST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Ulm
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Manfred Weiss, University of Ulm
ClinicalTrials.gov Identifier:
NCT00710411
First received: July 2, 2008
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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


Condition
Multiple Trauma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Inflammatory Response in Polytraumatized Patients

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Inflammatory pattern of complement activation, biomarkers and complement-regulating proteins (CRegs)on leukocytes [ Time Frame: 0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 90
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
A, 2
Polytraumatized patients with ISS > 18 and healthy controls

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Polytraumatized patients with an ISS > 18 Controls: healthy volunteers

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710411

Contacts
Contact: Manfred M Weiss, MD, MBA +49 - (0)731-500-60226 manfred.weiss@uniklinik-ulm.de
Contact: Markus M Huber-Lang, MD +49 - (0)731-500-54569 markus.huber-lang@uniklinik-ulm.de

Locations
Germany
Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery Recruiting
Ulm, Germany, 89070
Contact: Manfred M Weiss, MD, MBA    +49-(0)731-500-60226    manfred.weiss@uniklinik-ulm.de   
Contact: Markus M Huber-Lang, MD    +49-(0)731-500-54569    markus.huber-lang@uniklinik-ulm.de   
Principal Investigator: Markus M Huber-Lang, MD         
Sub-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         
Principal Investigator: Ludger L Sunder-Plassmann, MD         
Sub-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         
Sponsors and Collaborators
University of Ulm
German Research Foundation
Investigators
Principal Investigator: Manfred M Weiss, MD, MBA Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany
  More Information

No publications provided

Responsible Party: Manfred Weiss, Professor, MD, MBA, University of Ulm
ClinicalTrials.gov Identifier: NCT00710411     History of Changes
Other Study ID Numbers: DFG KFO-200
Study First Received: July 2, 2008
Last Updated: February 5, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University of Ulm:
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

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014