Study of Fibrinogen Metabolism During Severe Trauma and Burns

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588796
• Other study ID #: H-04-017
• Status: Completed
• Phase: N/A
• First received: December 25, 2007
• Last updated: February 2, 2015
• Start date: February 2005
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Major Trauma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

References & Publications (1)

Zuckerman L, Caprini JA, Lipp V, Vagher JP. Disseminated intravascular multiple systems activation (DIMSA) following thermal injury. J Trauma. 1978 Jun;18(6):432-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated		7	No
Secondary	Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism		7 days	No