The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are:
* Is it feasible to conduct a larger definitive trial? * Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples?
Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better.
Participants will:
* Provide written informed consent * Receive tranexamic acid during surgery * Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.
≥18 years of age
Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
Provide written informed consent
Allergy to tranexamic acid
Estimated glomerular filtration rate <30 mL/min (CKD-EPI equation) or on dialysis
Pre-operative hemoglobin >170 g/L
Expected circulatory arrest
Parallel
Before CPB Tranexamic Acid
DrugTranexamic acid 1 to 10 g (10 to 100 mL) administered intravenously as per standard care at the induction of anesthesia as a bolus and/or continuous infusion (i.e., before CPB).
After CPB Tranexamic Acid
DrugTranexamic acid 5 g (50 mL) administered after heparin reversal (i.e., after CPB).
Before CPB Placebo
DrugPlacebo (10 to 100 mL saline) administered intravenously at the induction of anesthesia as a bolus and/or continuous infusion.
After CPB Placebo
DrugPlacebo (50 mL saline) administered after heparin reversal.
Measure the level of plasma TxA at 5 time points
Measure the level of plasma TxA at 5 time points: pre-operative, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.
Measure the clot lysis time (i.e., fibrinolytic activity) at 5 time points
Measure the clot lysis time (i.e., fibrinolytic activity) at 5 time points: pre-operative baseline, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.
Measure the plasmin generation (i.e., fibrinolytic activity) at 5 time points
Measure the plasmin generation (i.e., fibrinolytic activity) at 5 time points: pre-operative baseline, on arrival in the intensive care unit, 3 hours after arrival, 6 hours after arrival, and the next morning.
Feasibility outcome (study-level): mean enrollment rate of the study
Determine whether the mean enrolment rate of the trial (total number of patients recruited / total recruitment period in weeks) is 2 patients per week or more.
Feasibility outcome (study-level): crossover rate of the study
Determine whether the percentage of crossovers between groups (total number of patients with crossover / total number of patients recruited \* 100) is less than 5%.
Feasibility outcome (study-level): percentage of data completion of the study
Determine whether the percentage of data completion (total number of patients with complete outcome data / total number of patients enrolled \* 100) is more than 95%.
Proportion of patients experiencing an in-hospital seizure
Appropriate descriptive statistics will be provided.
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This trial is not recruiting at the moment. You can still explore other options:
