Study of Fibrinogen Metabolism During Severe Trauma and Burns

United States Army Institute of Surgical Research

Status: Completed

Conditions: Major Trauma; Burn Injury

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT00588796

H-04-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Healthy Volunteers

Description:

Healthy Volunteers

Burn patients

Description:

Patients who have sustained burn injury greater than or equal to 20% of total body surface area

Trauma patients

Description:

Patients who have undergone trauma