Immune-cell Membrane Trafficking

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. Identifier: NCT00638521
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : December 11, 2013
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Joseph Cuschieri, University of Washington

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

Condition or disease
Severe Trauma

Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trauma and Sepsis Induced Changes in Immune-cell Membrane Receptor Trafficking
Study Start Date : June 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Assessment of protein and lipid changes in immune cells following severe injury [ Time Frame: 5/08 to 8/12 ]

Secondary Outcome Measures :
  1. Assessment of severe injury effect on plasma and cellular lipid content [ Time Frame: 5/08 to 8/12 ]

Biospecimen Retention:   Samples Without DNA
whole blood

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inclusion criteria:

Inclusion Criteria:

  • age 18 years or older, blunt or penetrating trauma and
  • one or more of the following: systolic blood pressure less than 90 mmHg at the scene or within one hour of arrival to the Emergency Department, 2) base deficit ≥ -6 within one hour of admission, 3) ISS greater than 25, or 4) more than 6 units of blood transfused in the first 12 hours.-

Exclusion Criteria:

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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 identifier (NCT number): NCT00638521

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Joseph Cuschieri, MD University of Washington

Responsible Party: Joseph Cuschieri, Study Principal Investigator, University of Washington Identifier: NCT00638521     History of Changes
Other Study ID Numbers: 31888-A
GM078054-01 ( Other Identifier: National Institute of General Medical Sciences (NIGMS) )
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by Joseph Cuschieri, University of Washington:
lipid raft