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Chronology of Occult and Gross Coagulopathy in Burn Patients

This study is not yet open for participant recruitment.
Verified July 2012 by Medstar Research Institute
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01638481
First received: July 9, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of the study is to identify the inflammatory and coagulation pathways and mechanisms that are activated immediately following burn injury, and how they affect outcomes in terms of organ failure and death. This study also addresses the limitation of current tests (PT, PTT, and platelet counts) employed to identify coagulation disturbances in severely injured patients both in a comprehensive and rapid manner.


Condition
Thermal Burns

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Estimated Enrollment: 85
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group #1 - Burns affecting less than 10% BSA
Group #2 - Burns affecting 10%-30% TBSA
Group #3 - Burns affecting 31%-50% TBSA
Group #4 - Burns affecting 51%-70% TBSA
Group #5 - Burns affecting >70% TBSA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Burn injury patients will be enrolled in the study upon arrival at Trauma Center.

Criteria

Inclusion Criteria:

  • Patients, male or female, > or = 18 years of age, who arrive at Burn/Trauma Center with anticipated admission to The Burn Center within 4 hours of injury, with a thermal burn injury due to flash, flame, contact with hot object or liquid.

Exclusion Criteria:

  • Patients suffering concomitant trauma that are in hemorrhagic shock. Patients with a preexisting history of coagulopathy, or currently taking anti-coagulants. Children and pregnant women. Patients with chemical or electrical injury. Patients who do not fluently speak either English or Spanish.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638481

Contacts
Contact: Michelle Mendoza, MD, CCRC 202-877-6181 michelle.mendoza@medstar.net

Locations
United States, District of Columbia
Washington Hospital Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Jeffrey Shupp, MD            
Sponsors and Collaborators
Medstar Research Institute
Department of Defense
Investigators
Principal Investigator: Jeffrey Shupp, MD Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01638481     History of Changes
Other Study ID Numbers: 58802-LS
Study First Received: July 9, 2012
Last Updated: July 10, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Burns
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013