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Study of Fibrinogen Metabolism During Severe Trauma and Burns

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00588796
Enrollment
30
Registered
2008-01-09
Start date
2005-02-28
Completion date
2014-01-31
Last updated
2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury, Major Trauma

Keywords

fibrinogen, burns, trauma, metabolism

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.

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.

Interventions

None listed

Sponsors

United States Army Institute of Surgical Research
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated7

Secondary

MeasureTime frame
Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism7 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026