Study of Fibrinogen Metabolism During Severe Trauma and Burns

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Burn patients Trauma patients Healthy Volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated	7

Secondary Outcome Measures

Outcome Measure	Time Frame
Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism	7 days

Collaborators and Investigators

• Sponsor: United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Wenjun Z Martini, PhD, United States Army Institute of Surgical Research

Publications and helpful links

General Publications

• Zuckerman L, Caprini JA, Lipp V, Vagher JP. Disseminated intravascular multiple systems activation (DIMSA) following thermal injury. J Trauma. 1978 Jun;18(6):432-9. doi: 10.1097/00005373-197806000-00008.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 25, 2007
• First Submitted That Met QC Criteria: January 8, 2008
• First Posted (Estimate): January 9, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: trauma; burns; metabolism; fibrinogen
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: H-04-017