Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery

Korábbi kezelés

• Contraindication or clinically relevant precaution to tranexamic acid according to the applicable product information, including:
  • active arterial or venous thromboembolic disease or active intravascular clotting;
  • history of subarachnoid hemorrhage;
  • acquired defective color vision;
  • clinically relevant seizure disorder or previous tranexamic-acid-associated seizure;
  • disseminated intravascular coagulation without predominant hyperfibrinolysis;
  • active upper urinary tract hematuria with a risk of ureteric obstruction.

Más betegség

• Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
• Hypersensitivity to tranexamic acid or any excipient of the study products.
• Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.

Egyéb

• Inability to provide informed consent or comply with the required follow-up.
• Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
• Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.
• Pregnancy or breastfeeding.
• Participation in another interventional clinical trial that could interfere with study outcomes or safety.
• Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.
• Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.

• Age 18 years or older.
• Elective isolated coronary artery bypass grafting planned without cardiopulmonary bypass, including off-pump coronary artery bypass through sternotomy or minimally invasive/direct or totally endoscopic coronary artery bypass surgery. Conversion to cardiopulmonary bypass is permitted if clinically required.
• Perioperative tranexamic acid planned as part of routine care, with the participant eligible for both oral and intravenous administration according to the applicable product information and local policy.
• Written informed consent obtained before randomization.
• Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.
• Available for in-hospital follow-up and Day 30 assessment.