Study of Fibrinogen Metabolism During Severe Trauma and Burns

This study is currently recruiting participants.

Verified by United States Army Institute of Surgical Research, January 2009

First Received: December 25, 2007 Last Updated: January 15, 2009 History of Changes

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00588796

Purpose

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
Severe Burns Major Trauma

MedlinePlus related topics: Burns Injuries Wounds

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Alteration in Fibrinogen Metabolism in Patients With Severe Burns and Traumatic Injuries

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

During the flow phase following burn or trauma injury, fibrinogen degradation is accelerated [ Time Frame: 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fibrinogen degradation stimulates fibrinogen synthesis at the expense of whole body protein catabolism [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Healthy
B Burn
C 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Burn patients Trauma patients Healthy Volunteers

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588796

Contacts

Contact: Wenjun Z Martini, PhD	210-916-4573	wenjun.martini@amedd.army.mil
Contact: Annette R McClinton, RN, MA	210-916-2834	annette.mcclinton@amedd.army.mil

Locations

United States, Texas
U.S. Army Institute of Surgical Research	Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Annette R McClinton, RN, MA 210-916-2834 annette.mcclinton@amedd.army.mil
Contact: Lynn C Platteborze, MS 210-916-9531 lynn.platteborze@amedd.army.mil
Principal Investigator: Wenjun Z Martini, PhD

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Wenjun Z Martini, PhD

United States Army Institute of Surgical Research

More Information

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.

Responsible Party:	USAISR ( Wenjun Z. Martini, PhD )
Study ID Numbers:	H-04-017
Study First Received:	December 25, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00588796 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

fibrinogen
burns
trauma
metabolism

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009