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Inflammatory Cytokine Variations in Traumatic Injury Responses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Alabama at Birmingham.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00593892
First received: January 3, 2008
Last updated: August 3, 2010
Last verified: August 2010
History of Changes
  Purpose

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
Inflammatory Cytokine Variations Following Traumatic Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cytokine Liberation From Secondary Surgery in the Setting of the Second Hit Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study Director: David A. Volgas, MD The University of Alabama at Birmingham
Principal Investigator: Ashley R. Estes, MD The University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: David A. Volgas, MD, Associate Professor of Surgery, Orthopaedic Division, The University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00593892     History of Changes
Other Study ID Numbers: F070425005, OTA 000306032
Study First Received: January 3, 2008
Last Updated: August 3, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013