Inflammatory Response After Muscle and Skeleton Trauma (IRAMST)

December 16, 2015 updated by: Manfred Weiss, University of Ulm

Inflammatory Response in Polytraumatized Patients

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89070
        • Clinic of Anesthesiology and Clinic of Traumatology, Hand-, Plastic-, and Reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Polytraumatized patients with an ISS > 18 Controls: healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A, 2
Polytraumatized patients with ISS > 18 and healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 1, 4, 12, 24, 48, 96, 120 und 240 h after trauma

Secondary Outcome Measures

Outcome Measure
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Manfred M Weiss, MD, MBA, Clinic of Anesthesiology, University Hospital Medical School, Steinhoevelstrasse 9, 89070 Ulm, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFG KFO-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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