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Clinical Trials/NCT00588796
NCT00588796CompletedNot Applicable

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

United States Army Institute of Surgical Research0 sites30 target enrollmentStarted: February 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Primary Endpoint
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor
United States Army Institute of Surgical Research
Sponsor Class
Fed
Responsible Party
Sponsor

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