Immune-cell Membrane Trafficking

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Cuschieri, University of Washington
ClinicalTrials.gov Identifier:
NCT00638521
First received: March 12, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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
Severe Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trauma and Sepsis Induced Changes in Immune-cell Membrane Receptor Trafficking

Resource links provided by NLM:


Further study details as provided by University of Washington:

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 ]

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 ]

Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 213
Study Start Date: June 2008
Study Completion Date: June 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion criteria:

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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00638521

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Joseph Cuschieri, MD University of Washington
  More Information

No publications provided

Responsible Party: Joseph Cuschieri, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00638521     History of Changes
Other Study ID Numbers: 31888-A, GM078054-01
Study First Received: March 12, 2008
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
lipids
proteins
membrane
lipid raft

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 29, 2014