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Inflammation and Infection in Trauma, Role in Posttraumatic Complications

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Unknown status
CT.gov ID
NCT00192907
Collaborator
(none)
380
Enrollment
1
Location
30.1
Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The immune system plays a role in the development of complications after severe trauma, but we do not know how. Equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, GC-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. Two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality.

    In the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. We compare the changes in between groups of the cohort.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Study Start Date :
    Mar 1, 2003
    Study Completion Date :
    Sep 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Clinical suspicion of multiple trauma

      • Age >/= 18 years

      • Direct referral from scene of accident

      Exclusion Criteria:

      • Major burn injury

      • HIV positiv

      • Pregnancy

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Rigshospitalet, Copenhagen University Hospital DK-2100 Copenhagen Denmark

      Sponsors and Collaborators

      • Rigshospitalet, Denmark

      Investigators

      • Study Chair: Jakob Stensballe, MD, Rigshospitalet, Denmark

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00192907
      Other Study ID Numbers:
      • KF 01-160/02 Main
      First Posted:
      Sep 19, 2005
      Last Update Posted:
      Sep 19, 2005
      Last Verified:
      Sep 1, 2005
      Additional relevant MeSH terms:
      Wounds and Injuries

      Study Results

      No Results Posted as of Sep 19, 2005