About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective cardiac surgery using cardiopulmonary bypass
Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.
Disqualifiers
Age below 18 years
Patient refusal
Pregnancy
End-stage renal disease
Trial design
Parallel
Treatments tested in this trial
Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h
DrugGroup 1: administration of tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h
Tranexamic acid at a dose of 20 mg/kg
DrugGroup 2: administration of tranexamic acid at a dose of 20 mg/kg
Tranexamic acid at a dose of 30 mg/kg
DrugGroup 3: administration of tranexamic acid at a dose of 30 mg/kg
Treatment groups
Trial outcomes
Primary outcomes
duration of inhibition of fibrinolysis as measured by the ClotPro-TPA test
time(hours) from tranexamic acid administration until the values of ML and LT in the TPA test (Clot Pro) become greater than 50% and less than 2100 sec, respectively (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration).
tranexamic blood concentration
Blood concentration of tranexamic acid at predifined study time points (0,3,6,12,24,36,48 etc up to 240 hours post tranexamic acid bolus administration)
Secondary outcomes
transfusion of blood and products
Patient's transfusion requirements for packed red blood cell units, fresh frozen plasma units and platelets units.
need of administration of coagulation factors
Need for administration of coagulation factors such as fibrinogen (gr), prothrombin complex concentrate, PCC (IU) and calcium (gr)
Postoperative bleeding
The total amount of blood present in the drainage tube in ml.
reoperation
The need for reoperation due to postoperative bleeding
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