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Chronology of Occult and Gross Coagulopathy in Burn Patients

This study is currently recruiting participants.
Verified July 2016 by Medstar Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01638481
First Posted: July 11, 2012
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Medstar Health Research Institute
July 9, 2012
July 11, 2012
July 14, 2016
July 2012
December 2016   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01638481 on ClinicalTrials.gov Archive Site
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Chronology of Occult and Gross Coagulopathy in Burn Patients
Determining the Chronology of Occult and Gross Coagulopathy in Thermally Injured Patients: A Systems Biology Approach
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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Burn injury patients will be enrolled in the study upon arrival at Trauma Center.
Thermal Burns
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
June 2017
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Melissa McLawhorn 202-877-6181 melissa.m.mclawhorn@medstar.net
United States
 
 
NCT01638481
58802-LS
No
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Medstar Health Research Institute
Medstar Health Research Institute
United States Department of Defense
Principal Investigator: Jeffrey Shupp, MD Washington Hospital Center
Medstar Health Research Institute
July 2016