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Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery

RecruitingNAAges 18 Years - 99 YearsAllUniversity of Ioannina
NCT07164300 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h
  • Tranexamic acid at a dose of 20 mg/kg
  • Tranexamic acid at a dose of 30 mg/kg
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Where

1 site
University Hospital of Ioannina
Ioannina, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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