Thromboelastography for Burns

Overseen By Hilary Y Liu, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Francesco Egro

Disqualifiers: Venous thromboembolism, Hyper/hypocoagulopathy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Thromboelastography for burns?

Thromboelastography (TEG) is a test that helps evaluate blood clotting and has been shown to improve care outcomes in cardiac surgery patients by reducing the need for blood transfusions. It may also be useful for burn patients to assess and manage blood clotting issues, which are common in severe burns. ^{1 2 3 4 5}

Is thromboelastography safe for use in humans?

Thromboelastography is generally used safely in humans to monitor blood clotting during surgeries and in critical care settings. However, there can be variability in results due to different testing methods and patient conditions, which may affect its reliability in predicting bleeding or clotting risks. ^{6 7 8 9 10}

How does thromboelastography treatment differ from other treatments for burns?

Thromboelastography (TEG) is unique because it evaluates the blood's ability to clot in real-time, providing rapid and detailed information about a burn patient's coagulation status, which can help guide treatment decisions. Unlike standard blood tests, TEG assesses the whole blood's clotting process, making it particularly useful for patients with complex clotting issues often seen in severe burns. ^{5 6 9 11 12}

What is the purpose of this trial?

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.

Research Team

Francesco M Egro, MD, MSc, MRCS

Principal Investigator

Department of Plastic Surgery, University of Pittsburgh Medical Center

Eligibility Criteria

This trial is for burn patients. It's looking at how their injuries affect blood clotting. To join, people must have a certain percentage of their body burned but the exact criteria aren't specified here.

Inclusion Criteria

Provided consent to participate in the study

I was recently admitted for a burn injury.

Exclusion Criteria

I have a history of blood clots or abnormal blood clotting.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo thromboelastography (TEG) testing to evaluate clotting abnormalities over a 4-week period

4 weeks

5 visits (in-person) on Day 1, Day 7, Day 14, Day 21, and Day 28

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking hospital length of stay and complications

4 weeks

Treatment Details

Interventions

• Thromboelastography

Trial Overview The study uses thromboelastography (TEG), a test that measures blood clots, to see how burn injuries change clotting over time and if this can predict recovery or complications.

Participant Groups

Group I: Burn Thromboelastography Group Experimental Treatment 1 Intervention

Overall study population (all participants are in the same group). See eligibility for further details.

Who Is Running the Clinical Trial?

Francesco Egro

Lead Sponsor

Trials

2

Recruited

320+

References

1. United States pubmed.ncbi.nlm.nih.gov

Thromboelastography: a means to transfusion reduction. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Burn-Induced Coagulopathies: a Comprehensive Review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Is major burn injury associated with coagulopathy? The value of thrombelastometry in the detection of coagulopathy in major burn injury: A prospective observational study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical significance of R-TEG in severe burn patients with coagulation dysfunction. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Characteristics of blood clotting on thromboelastography in patients with early burns. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Principles and practice of thromboelastography in clinical coagulation management and transfusion practice. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Monitoring of blood coagulation with non-contact drop oscillation rheometry. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Role of thrombolestagrophy in monitoring perioperative coagulation status and effect of thromboprophylaxis in bariatric surgery. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of Rapid, Kaolin, and Native TEG Parameters in Burn Patient Cohorts with Acute Burn-Induced Coagulopathy and Abnormal Fibrinolytic Function. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of aprotinin on thromboelastography with three different activators. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A Review of Thromboelastography for Nurses. [2023]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

[Thromboelastography--an instrument for the researcher or clinician?]. [2006]