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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014