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Study of Fibrinogen Metabolism During Severe Trauma and Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00588796
Recruitment Status : Completed
First Posted : January 9, 2008
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Brief 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.

Condition or disease
Burn Injury Major 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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries
Study Start Date : February 2005
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Healthy Volunteers
Healthy Volunteers
Burn patients
Patients who have sustained burn injury greater than or equal to 20% of total body surface area
Trauma patients
Patients who have undergone trauma

Primary Outcome Measures :
  1. During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated [ Time Frame: 7 ]

Secondary Outcome Measures :
  1. Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Burn patients Trauma patients 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00588796

Sponsors and Collaborators
United States Army Institute of Surgical Research
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Principal Investigator: Wenjun Z Martini, PhD United States Army Institute of Surgical Research
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Responsible Party: United States Army Institute of Surgical Research Identifier: NCT00588796    
Other Study ID Numbers: H-04-017
First Posted: January 9, 2008    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by United States Army Institute of Surgical Research:
Additional relevant MeSH terms:
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Wounds and Injuries