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

Overview

Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established. TRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction. The primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.

Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration. TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting. A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups: 1. Oral tranexamic acid group: four 500 mg tranexamic acid tablets administered approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol. 2. Intravenous tranexamic acid group: four matching oral placebo tablets administered approximately 2 hours before surgical incision, together with 1 g intravenous tranexamic acid administered at induction or incision according to the study protocol. Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy. The primary objective is to assess whether oral tranexamic acid is non-inferior to intravenous tranexamic acid in reducing postoperative blood loss following off-pump coronary artery bypass grafting. Secondary and safety outcomes will assess perioperative transfusion requirements, postoperative hemoglobin changes, clinically significant bleeding, reoperation for bleeding, thromboembolic events, seizures, acute kidney injury, mortality, duration of intensive care and hospital stay, and other postoperative complications specified in the protocol.