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Tracking Information | |||||
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First Received Date † | March 12, 2008 | ||||
Last Updated Date | December 31, 2008 | ||||
Start Date † | June 2008 | ||||
Current Primary Outcome Measures † |
Assessment of protein and lipid changes in immune cells following severe injury [ Time Frame: 5/08 to 8/12 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00638521 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Assessment of severe injury effect on plasma and cellular lipid content [ Time Frame: 5/08 to 8/12 ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Immune-Cell Membrane Trafficking | ||||
Official Title † | Trauma and Sepsis Induced Changes in Immune-Cell Membrane Receptor Trafficking | ||||
Brief Summary | Organ failure following trauma is a leading cause of morbidity and mortality. It appears that the development of organ failure is a direct result of an altered immune response. This altered response results in the production of circulating factors in the blood that causes direct injury to the injured patients' organs. The mechanism in which this altered immune response occurs is unknown. Based on work we have performed in our laboratory, we believe that this response is initiated on the cell membrane of particular immune cells known as macrophages. Although the cell membrane may appear uniform, it is not. The membrane is composed of specific segments that allow proteins to associate with each other forming receptors that are required for immune cell activation. These specific membrane components are composed of various lipids and cholesterol, and have been termed lipid rafts. Based on our laboratory work it appears that these lipid rafts can be altered following injury. In particular both the lipid and protein content within these raft segments may be altered allowing immune cells to become active leading to the production of factors that directly injure normal cells and organs. Thus, we plan to examine if these laboratory findings can be seen in patients suffering from trauma who develop clinical organ failure at Harborview Medical Center. If this is accomplished, this data will lead to the development of both prognostic and therapeutic interventions for the optimal care of injured patient |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Cohort, Prospective | ||||
Condition † | Severe Trauma | ||||
Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 250 | ||||
Estimated Completion Date | August 2012 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00638521 | ||||
Responsible Party | Joseph Cuschieri, MD: Associate Professor, Department of Surgery, University of Washington | ||||
Secondary IDs †† | GM078054-01 | ||||
Study Sponsor † | University of Washington | ||||
Collaborators †† | National Institute of General Medical Sciences (NIGMS) | ||||
Investigators † |
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Information Provided By | University of Washington | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |