Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Recruiting now · Not applicable
Conditions studied: Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event, Fibrinolysis; Hemorrhage, Tranexamic Acid Adverse Reaction
In brief
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. The purpose of this study is to compare different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass regarding the duration of inhibition of fibrinolysis as measured by the ClotPro test. Blood samples will be taken from the arterial line placed in the patient at specified time points in order to perform viscoelastic tests (ClotPro, TPA test), to detect successful inhibition of fibrinolysis and to measure tranexamic acid levels in the patient's blood. In case the action of tranexamic acid stops early postoperatively an additional dose of the medication will be administered to the patient.
Key facts
- Study ID
- NCT07164300
- Run by
- University of Ioannina
- People needed
- 150
- Starts
- 2024-05-14
- Expected to finish
- 2027-12-15
- Last updated by the study team
- 2025-09-10
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing elective cardiac surgery using cardiopulmonary bypass
- Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.
You may not qualify if…
- 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 is running
- University Hospital of Ioannina — Ioannina, Greece (enrolling)
Full record on ClinicalTrials.gov
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