Thromboelastography (TEG)NCT07366606
Bleeding Management İn Open Heart Surgery
A study testing Blood Product in people with Thromboelastography (TEG) and Open Heart Surgery, run by Serkan Uckun.
Trial summary
This study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Thromboelastography (TEG), Open Heart Surgery, Bleeding
- What is being tested?
- Blood Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo open heart surgery
- Patients who have given informed consent
Who cannot join
- Patients undergoing emergency surgery
- Patients with known congenital coagulation disorders
- Patients with a known history of bleeding diathesis
- Patients receiving uninterrupted anticoagulant therapy at an optimal time
- Patients with renal failure under dialysis treatment
- Patients with active malignancy
- Patients who did not provide informed consent
About this study
Official title: Development of a Thromboelastography-Based Algorithm for Targeted Bleeding Management in Open Heart Surgery: An In Vitro Clinical Study
This study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. The study is prospective, in vitro, and non-invasive. The material will consist of residual blood samples from open heart surgery patients. Analyses will be performed using TEG parameters (R time, K time, MA, LY30). Patients will be randomized using a closed-envelope method and divided into two groups: anesthesiologist standard clinical observation-control (Group K) and anesthesiologist standard clinical observation and TEG analysis (Group T). The sample size is 70 patients per group. From an ethical standpoint, this study uses anonymous data without additional blood collection and ensures patient safety.
- Conditions
- Thromboelastography (TEG), Open Heart Surgery, Bleeding
- Being tested
- Blood Product
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood ProductDiagnostic test
R time, the time from the start of the test until the graph width reaches 2 mm (5-10 minutes), reflects the activity of clotting factors.
K time, the time from the end of R until the width reaches 20 mm (1-3 minutes), represents the clot formation time and rate.
alpha angle (53-72 degrees) represents fibrinogen function, maximum amplitude is related to platelet function (50-70 mm), represents maximum clot strength.
lysis rate -30 (0% -8%) represents the clot lysis rate 30 minutes after MA, indicating whether hyperfibrinolysis is present.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The decision regarding blood and blood product transfusions will be made based on clinical observation by an anesthesiologist, which is our current routine practice. |
| Group T | Active comparator | Blood clotting tests are performed with the device. Receives: Diagnostic Test: Blood Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted coagulation therapy
Measurement of R time using thromboelastography Measurement of K time using thromboelastography Measurement of maximum amplitude using thromboelastography
Measured: A total of three measurements will be take After induction of anesthesia (Between 15 and 30 minutes of the operation) During cardiopulmonary bypass (2 hours after the start of surgery) Following cardiopulmonary bypass (4 hours after the start of surgery)
Secondary outcomes (1)
Use of blood products
Optimizing the use of fibrinogen, platelets, and fresh frozen plasma by combining thromboelastography measurements with clinical interpretation
Measured: Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboelastography (TEG)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serkan Uckun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serkan Uckun, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366606
- Sponsor's protocol ID
- AHTEG
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Thromboelastography-Based Algorithm for Targeted Bleeding Management in Open Heart Surgery: An In Vitro Clinical Study
- ClinicalTrials.gov ID
- NCT07366606
- Acronym / sponsor ID
- AHTEG
- Conditions
- Thromboelastography (TEG), Open Heart Surgery, Bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Serkan UckunUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2026 (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 study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. The study is prospective, in vitro, and non-invasive. The material will consist of residual blood samples from open heart surgery patients. Analyses will be performed using TEG parameters (R time, K time, MA, LY30). Patients will be randomized using a closed-envelope method and divided into two groups: anesthesiologist standard clinical observation-control (Group K) and anesthesiologist standard clinical observation and TEG analysis (Group T). The sample size is 70 patients per group. From an ethical standpoint, this study uses anonymous data without additional blood collection and ensures patient safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The decision regarding blood and blood product transfusions will be made based on clinical observation by an anesthesiologist, which is our current routine practice. |
| Group T | Active comparator | Diagnostic Test: Blood ProductBlood clotting tests are performed with the device. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo open heart surgery
- Patients who have given informed consent
Key exclusion criteria (7 listed)
- Patients undergoing emergency surgery
- Patients with known congenital coagulation disorders
- Patients with a known history of bleeding diathesis
- Patients receiving uninterrupted anticoagulant therapy at an optimal time
- Patients with renal failure under dialysis treatment
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 |
|---|---|---|
| Blood ProductR time, the time from the start of the test until the graph width reaches 2 mm (5-10 minutes), reflects the activity of clotting factors. K time, the time from the end of R until the width reaches 20 mm (1-3 minutes), represents the clot formation time and rate. alpha angle (53-72 degrees) represents fibrinogen function, maximum amplitude is related to platelet function (50-70 mm), represents maximum clot strength. lysis rate -30 (0% -8%) represents the clot lysis rate 30 minutes after MA, indicating whether hyperfibrinolysis is present. | Diagnostic test | Group T |
Primary outcome
Targeted coagulation therapy
Time frame: A total of three measurements will be take After induction of anesthesia (Between 15 and 30 minutes of the operation) During cardiopulmonary bypass (2 hours after the start of surgery) Following cardiopulmonary bypass (4 hours after the start of surgery)
Measurement of R time using thromboelastography Measurement of K time using thromboelastography Measurement of maximum amplitude using thromboelastography
1 secondary outcome
Use of blood products
Time frame: Anesthesia continues during cardiopulmonary bypass exit (4 to 5 hours after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Related trials for Thromboelastography (TEG)
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingObservational study
DDAVP Effect by TEG6 in Cardiac Surgery
Intraoperative Bleeding
Recruiting
Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease
Peripheral Arterial Disease (PAD), Amputation
RecruitingObservational study
Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)
Blood Platelet Disorders, Cardiac Surgery
RecruitingObservational study
Usefulness of Thromboelastography as a Predictor of Prognosis in Patients Undergoing Surgery for Glial Tumors and of the Risk of Postoperative Thromboembolic Disease (GliTEM)
Glial Tumors, Thrombosis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Product in people with Thromboelastography (TEG) and Open Heart Surgery, run by Serkan Uckun.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Targeted coagulation therapy (time frame: A total of three measurements will be take After induction of anesthesia (Between 15 and 30 minutes of the operation) During cardiopulmonary bypass (2 hours after the start of surgery) Following cardiopulmonary bypass (4 hours after the start of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.