Study of Fibrinogen Metabolism During Severe Trauma and Burns

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00588796
First received: December 25, 2007
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition
Severe Burns
Major Trauma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated [ Time Frame: 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Healthy
B
Burn
C
Trauma

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Burn patients Trauma patients Healthy Volunteers

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00588796

Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Wenjun Z Martini, PhD United States Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00588796     History of Changes
Other Study ID Numbers: H-04-017
Study First Received: December 25, 2007
Last Updated: June 5, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
fibrinogen
burns
trauma
metabolism

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014