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Clinical Trials/NCT00588796
NCT00588796
Completed
Not Applicable

Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries

United States Army Institute of Surgical Research0 sites30 target enrollmentFebruary 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burn Injury
Sponsor
United States Army Institute of Surgical Research
Enrollment
30
Primary Endpoint
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

To study the fibrinogen metabolic changes in relation to coagulation disorder in patients with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of fibrinogen is accelerated.

Detailed Description

In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients, using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine, 2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen synthesis and degradation. Stable isotopes are non-radioactive.

Registry
clinicaltrials.gov
Start Date
February 2005
End Date
January 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
United States Army Institute of Surgical Research
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 20% total body surface area burn or more
  • severe trauma with injury severity score greater than 10
  • between ages of 18 and 65 years

Exclusion Criteria

  • history of blood clotting disorder
  • history of liver disease such as cirrhosis or hepatitis
  • pregnant or nursing
  • allergic to iodine, shellfish or dye used in X-Rays
  • taking long term medications for blood clotting usch as Coumadin or Plavix
  • prisoners
  • receiving total parenteral nutrition

Outcomes

Primary Outcomes

During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated

Time Frame: 7

Secondary Outcomes

  • Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism(7 days)

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