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Completed

NCT Number: NCT00588796

Study of Fibrinogen Metabolism During Severe Trauma and Burns

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.

Completed

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Key information

Conditions

Burn Injury Burns Major Trauma Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated

    Time frame: 7

Secondary outcomes

  1. Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

United States Army Institute of Surgical Research

Fed

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2008
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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