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Chronology of Occult and Gross Coagulopathy in Burn Patients

Sponsor
Medstar Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01638481
Collaborator
United States Department of Defense (U.S. Fed)
158
Enrollment
1
Location
107
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    158 participants
    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
    Actual Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Mar 1, 2017
    Actual Study Completion Date :
    Jun 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 MedStar Washington Hospital Center Washington District of Columbia United States 20010

      Sponsors and Collaborators

      • Medstar Health Research Institute
      • United States Department of Defense

      Investigators

      • Principal Investigator: Jeffrey Shupp, MD, Medstar Health Research Institute

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Medstar Health Research Institute
      ClinicalTrials.gov Identifier:
      NCT01638481
      Other Study ID Numbers:
      • 58802-LS
      First Posted:
      Jul 11, 2012
      Last Update Posted:
      Feb 16, 2022
      Last Verified:
      Feb 1, 2022
      Additional relevant MeSH terms:
      Hemostatic Disorders
      Blood Coagulation Disorders

      Study Results

      No Results Posted as of Feb 16, 2022