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Inflammatory Cytokine Variations in Traumatic Injury Responses (Cytokine)

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ClinicalTrials.gov Identifier: NCT00593892
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : October 29, 2013
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to determine if the type of surgery (orthopaedic, general surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of multisystem organ failure.

Condition or disease
Traumatic Complication of Injury

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cytokine Liberation From Secondary Surgery in the Setting of the Second Hit Syndrome
Study Start Date : May 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Observation
All patients who are admitted to UAB for trauma, are 19 years of age and older, and whose Injury Severity Score (ISS) is greater than 9.



Primary Outcome Measures :
  1. Determine if the type of surgery (orthopaedic, general surgery, thoracic, etc.) affects the level of cytokines and thus potentially the risk of multisystem organ failure. [ Time Frame: Duration of patient's hospitalization ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UAB Patients treated for traumatic injuries
Criteria

Inclusion Criteria:

  • Adult patient 19 years and older
  • Sustained trauma injuries with Injury Severity Score greater than 9

Exclusion Criteria:

  • Under 19 years of age
  • Prisoners
  • Pregnancy
  • Unwilling or unable to give informed consent

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): NCT00593892


Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Orthopaedic Trauma Association
Investigators
Principal Investigator: Rena Stewart, MD The University of Alabama at Birmingham
Principal Investigator: Jason Lowe, MD The University of Alabama at Birmingham

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00593892     History of Changes
Other Study ID Numbers: F070425005
OTA 000306032 ( Other Identifier: OTA )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by University of Alabama at Birmingham:
Cytokine Levels
Traumatic Injury
Multisystem Organ Failure

Additional relevant MeSH terms:
Wounds and Injuries
Congenital Abnormalities