Comparing tranexamic acid dosing during heart surgery with cardiopulmonary bypass
Official title: Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass
Run by University of Ioannina · NCT07164300 · Data updated 2026-11-12
This research will test whether three different tranexamic acid dosing schedules keep fibrinolysis suppressed longer and limit bleeding in adults having elective heart surgery with cardiopulmonary bypass.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Ioannina Academic / other |
| Locations | 1 site (Ioannina) |
| Status | Recruiting |
| Started | May 14, 2024 |
| Main results expected | December 15, 2027 |
| Study ends | December 15, 2027 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07164300 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing elective cardiac surgery with cardiopulmonary bypass who have discontinued anticoagulant/antiplatelet therapy per guidelines and do not have contraindications such as epilepsy, pregnancy, end-stage renal disease, or allergy to tranexamic acid.
✕Probably not a fit
Patients having off-pump or emergency cardiac operations, pregnant patients, minors, those with end-stage renal disease, a history of epilepsy, or a known allergy to tranexamic acid are not expected to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for elective cardiac surgery with cardiopulmonary bypass are assigned to one of three tranexamic acid dosing regimens (10 mg/kg plus 1 mg/kg/h infusion, 20 mg/kg, or 30 mg/kg). Blood samples taken at predefined time points will be analyzed with the ClotPro TPA viscoelastic test to measure duration of fibrinolysis inhibition and tranexamic acid plasma levels. If antifibrinolytic activity ends early postoperatively, an additional dose may be given per protocol. The primary outcome is the duration of fibrinolysis suppression as measured by ClotPro, with safety monitoring for known tranexamic acid adverse events.
Why it matters
Potential benefit: If successful, the study could identify a dosing approach that provides sufficient antifibrinolysis while minimizing drug-related complications, potentially reducing bleeding and transfusion needs.
How similar studies have gone: A 2021 meta-analysis suggests lower tranexamic acid doses are safe and effective at reducing bleeding, but randomized trials using ClotPro to measure duration of fibrinolysis suppression are lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing elective cardiac surgery using cardiopulmonary bypass * Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines. Exclusion Criteria: * Age below 18 years * Patient refusal * Pregnancy * End-stage renal disease * History of epilepsy, * Cardiac surgery without the use of cardiopulmonary bypass (off-pump) * Emergency operations * Known allergy to the administered agents.
Where it's running
-
University Hospital of Ioannina
Ioannina, Greece Recruiting
Study contacts
- Principal investigator: Evangelia Samara — University of Ioannina
- Study coordinator: Evangelia Samara
- Email: gelysamara@uoi.gr
- Phone: 6972325749
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.