NCT00638521

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

4.2 years

First QC Date

March 12, 2008

Last Update Submit

December 10, 2013

Conditions

Keywords

lipidsproteinsmembranelipid raft

Outcome Measures

Primary Outcomes (1)

  • Assessment of protein and lipid changes in immune cells following severe injury

    5/08 to 8/12

Secondary Outcomes (1)

  • Assessment of severe injury effect on plasma and cellular lipid content

    5/08 to 8/12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inclusion criteria:

You may qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Joseph Cuschieri, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2012

Study Completion

June 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations