Study of Fibrinogen Metabolism During Severe Trauma and Burns

United States Army Institute of Surgical Research30 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Burn Injury Major Trauma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Time frame: 7 days

Data from ClinicalTrials.gov

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