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.
Inclusion Criteria:
Exclusion Criteria:
Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
Inability to provide informed consent or comply with the required follow-up.
Hypersensitivity to tranexamic acid or any excipient of the study products.
Contraindication or clinically relevant precaution to tranexamic acid according to the applicable product information, including:
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.
Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.
Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.
benjamin.javillier@slbo.be081 20 91 55 ext. +32
A double-dummy design is used. Participants receive either oral tranexamic acid and intravenous placebo or oral placebo and intravenous tranexamic acid. Participants, perioperative care providers, investigators, and outcome assessors are unaware of treatment allocation. The randomization list is held by the hospital pharmacy, with emergency unblinding available according to the protocol.
Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
Participants receive four matching oral placebo tablets approximately 2 hours before surgical incision, together with 1 g of intravenous tranexamic acid administered at induction or incision according to the study protocol.
Tranexamic Acid in Off-pump Coronary Surgery
The Effect of Tranexamic Acid on Postoperative Blood Loss and Coagulation in Patients With Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; Double Blind Randomized Control Study
Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery
Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation
Dose-ranging Study of Two Doses of Tranexamic Acid During Cardiac Surgery
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty
Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial