Thromboelastography to Study Burn Coagulopathy

NCT06879509 | Withdrawn FDA Device

• 1 other identifier: STUDY23120009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn; Coagulation, Blood

Keywords

burn; coagulation; Thromboelastography

Outcome Measures

Primary Outcomes (1)

• Thromboelastography

  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 Outcomes (2)

• Hospital Length of Stay

  Duration of hospital length of stay, up to 28 days

• Complications During Treatment

  Duration of hospital length of stay, up to 28 days

Study Arms (1)

Burn Thromboelastography Group

EXPERIMENTAL

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

Diagnostic Test: Thromboelastography

Interventions

Thromboelastography DIAGNOSTIC_TEST

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.

Also known as: TEG

Burn Thromboelastography Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Francesco Egro: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (2)

• Baumeister S, Koller M, Dragu A, Germann G, Sauerbier M. Principles of microvascular reconstruction in burn and electrical burn injuries. Burns. 2005 Feb;31(1):92-8. doi: 10.1016/j.burns.2004.07.014.

  PMID: 15639372 BACKGROUND

• Alessandri-Bonetti M, Kasmirski JA, Liu HY, Corcos AC, Ziembicki JA, Stofman GM, Egro FM. Impact of Microsurgical Reconstruction Timing on the Risk of Free Flap Loss in Acute Burns: Systematic Review and Meta-Analysis. Plast Reconstr Surg Glob Open. 2024 Aug 9;12(8):e6025. doi: 10.1097/GOX.0000000000006025. eCollection 2024 Aug.

  PMID: 39129846 BACKGROUND

MeSH Terms

Conditions

Burns; Thrombosis

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Wounds and Injuries; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Francesco M Egro, MD, MSc, MRCS

  Department of Plastic Surgery, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: March 17, 2025
• Study Start: January 1, 2026
• Primary Completion: February 1, 2026
• Study Completion: February 4, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)