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Inflammation and Infection in Trauma, Role in Posttraumatic Complications

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192907
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Rigshospitalet, Denmark
  Purpose
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
Trauma

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Estimated Enrollment: 380
Study Start Date: March 2003
Estimated Study Completion Date: September 2005
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.

  Eligibility

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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00192907     History of Changes
Other Study ID Numbers: KF 01-160/02 Main
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005