Study of Fibrinogen Metabolism During Severe Trauma and Burns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Burn Injury Major Trauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Burn patients

Patients who have sustained burn injury greater than or equal to 20% of total body surface area

No interventions assigned to this group

Trauma patients

Patients who have undergone trauma

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes