drugset / Trial / NCT07164300

Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

NCT07164300 ↗

Recruiting 150 enrolled University of Ioannina
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2024-05-14
Primary completion
2027-12-15
Completion
2027-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 mg/kg —
Subject Tranexamic Acid Small molecule 20 mg/kg —
Subject Tranexamic Acid Small molecule 30 mg/kg —