Thromboelastography to Study Burn Coagulopathy

March 10, 2025 updated by: Francesco Egro

The Use of Thromboelastography in Burn Injury to Improve Burn Coagulopathy Evaluation and Intervention

This pilot study examines the use of thromboelastography (TEG), a specialized blood test, to evaluate clotting abnormalities in burn patients. The study aims to understand how burn injuries impact the body's ability to form and break down blood clots over time. Specifically, the investigators will research whether the percentage of total body surface area burned (%TBSA) is associated with changes in blood clotting, track the evolution of clotting patterns during the first four weeks following a burn injury, and explore whether these changes can predict recovery or complications. By providing new insights into clotting dynamics in burn patients, the study seeks to improve diagnostic methods, enhance monitoring strategies, and guide treatments to optimize patient care and outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Francesco M Egro, MD
  • Phone Number: (404) 861-7944‬
  • Email: egrofm@upmc.edu

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh Medical Center
        • Contact:
        • Contact:
          • Francesco M Egro, MD
          • Phone Number: (404) 861-7944‬
          • Email: egrofm@upmc.edu
        • Contact:
          • Francesco M Egro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted with acute burn injuries
  • Aged 18 years and older
  • Provided consent to participate in the study

Exclusion Criteria:

  • Patients with a history of venous thromboembolism or hyper/hypocoagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Burn Thromboelastography Group
Overall study population (all participants are in the same group). See eligibility for further details.
Diagnostic test: Thromboelastography
All participants will receive this intervention. Thromboelastography (TEG) is a blood test that provides a detailed assessment of the clotting process, measuring how blood clots form, strengthen, and dissolve. It offers real-time insights into a patient's coagulation status, helping to identify clotting disorders and guide treatment decisions.
Other Names:
  • TEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboelastography
Time Frame: Duration of hospital length of stay, up to 28 days

Thromboelastography (TEG) evaluates blood's clotting ability by measuring the strength and elasticity of a clot over time, producing a dynamic graph. The following outcome measures will be assessed at specific time points (Day 1, Day 7, Day 14, Day 21, and Day 28):

  1. Reaction Time (R) (seconds) - The time from test initiation until the first detectable clot formation.
  2. Kinetic Time (K) (seconds) - The time from initial clot formation to a defined clot strength threshold.
  3. Maximum Amplitude (MA) (millimeters) - The peak strength of the formed clot.
  4. Alpha Angle (degrees) - The slope of the clot formation curve, representing the rate of clot development.
  5. Lysis at 30 Minutes (Ly30) (percentage of MA) - The percentage of clot degradation occurring 30 minutes after reaching maximum amplitude.

Each parameter will be measured at the specified time points, and values will be aggregated into one TEG graph.
Duration of hospital length of stay, up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: Duration of hospital length of stay, up to 28 days
The investigators will measure the number of days patients stay in the hospital for treatment.
Duration of hospital length of stay, up to 28 days
Complications During Treatment
Time Frame: Duration of hospital length of stay, up to 28 days
The investigators will record any complications, such as infections, graft loss, flap loss, or thrombosis that occur during treatment.
Duration of hospital length of stay, up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francesco Egro

Investigators

  • Principal Investigator: Francesco M Egro, MD, MSc, MRCS, Department of Plastic Surgery, University of Pittsburgh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY23120009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared upon reasonable request by the peer-reviewed journal in which this study is published, provided the request is in alignment with ethical and legal standards.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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