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.

Study Overview

• Status: Completed
• Conditions: Thermal Burns

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Jeffrey Shupp, MD, MedStar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: 58802-LS