BurnNCT06879509
Thromboelastography to Study Burn Coagulopathy
A study testing Thromboelastography in people with Burn and Coagulation, Blood, run by Francesco Egro at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Coagulation, Blood
- What is being tested?
- Thromboelastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with acute burn injuries
- Aged 18 years and older
- Provided consent to participate in the study
Who cannot join
- Patients with a history of venous thromboembolism or hyper/hypocoagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
About this study
Official title: 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.
- Conditions
- Burn, Coagulation, Blood
- Being tested
- Thromboelastography
- Keywords
- burn, coagulation, Thromboelastography
- Medical subject headings
- Burns, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyDiagnostic test
Also called TEG
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.
| Study group | Role | What they receive |
|---|---|---|
| Burn Thromboelastography Group | Experimental | Overall study population (all participants are in the same group). See eligibility for further details. Receives: Diagnostic Test: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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):
- Reaction Time (R) (seconds) - The time from test initiation until the first detectable clot formation.
- Kinetic Time (K) (seconds) - The time from initial clot formation to a defined clot strength threshold.
- Maximum Amplitude (MA) (millimeters) - The peak strength of the formed clot.
- Alpha Angle (degrees) - The slope of the clot formation curve, representing the rate of clot development.
- 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.
Measured: Duration of hospital length of stay, up to 28 days
Secondary outcomes (2)
Hospital Length of Stay
The investigators will measure the number of days patients stay in the hospital for treatment.
Measured: Duration of hospital length of stay, up to 28 days
Complications During Treatment
The investigators will record any complications, such as infections, graft loss, flap loss, or thrombosis that occur during treatment.
Measured: Duration of hospital length of stay, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion4 Feb 2026
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco Egro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco Egro, University of Pittsburgh
- Investigators
- Francesco M Egro, MD, MSc, MRCS, Principal investigator, Department of Plastic Surgery, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879509
- Sponsor's protocol ID
- STUDY23120009
- Status last verified
- Jul 2026
- First submitted
- 6 Dec 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 15639372Alessandri-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.
PubMed 39129846
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Thromboelastography in Burn Injury to Improve Burn Coagulopathy Evaluation and Intervention
- ClinicalTrials.gov ID
- NCT06879509
- Acronym / sponsor ID
- STUDY23120009
- Conditions
- Burn, Coagulation, Blood
- Keywords
- burn, coagulation, Thromboelastography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Francesco EgroUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn Thromboelastography Group | Experimental | Diagnostic Test: ThromboelastographyOverall study population (all participants are in the same group). See eligibility for further details. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted with acute burn injuries
- Aged 18 years and older
- Provided consent to participate in the study
Key exclusion criteria (1 listed)
- Patients with a history of venous thromboembolism or hyper/hypocoagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastographyAlso: TEGAll 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. | Diagnostic test | Burn Thromboelastography Group |
Primary outcome
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.
2 secondary outcomes
Hospital Length of Stay
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 15639372Baumeister 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.
- Background: PubMed 39129846Alessandri-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco M Egro, MD, MSc, MRCS principal investigator
Department of Plastic Surgery, University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboelastography in people with Burn and Coagulation, Blood, run by Francesco Egro at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboelastography (time frame: Duration of hospital length of stay, up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.