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Inflammation and Infection in Trauma, Role in Posttraumatic Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00192907
Recruitment Status : Unknown
Verified September 2005 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Information provided by:

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
Trauma

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
Estimated Enrollment : 380 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : March 2003
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192907


Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
DK-2100 Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Jakob Stensballe, MD Rigshospitalet, Denmark