Oral versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomised Non-Inferiority Trial (TRANSCAB Study)

Condition studied

Coronary artery disease requiring off-pump coronary artery bypass surgery (OPCAB)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Cumulative postoperative chest-tube drainage within 24 hours after surgery (mL).

Endpoint detail

Allogeneic red-blood-cell (RBC) transfusion (yes/no), Number of RBC units transfused, Calculated blood loss at 24 h (mL), Calculated blood loss at 48 h (mL), Intraoperative blood loss (mL), Chest-drain output at 12 h (mL), Time to chest-drain removal (hours), Postoperative haemoglobin at 24 h (g/dL), Nadir haemoglobin during index admission (g/dL), ICU length of stay (hours), Hospital length of stay (days), Re-exploration for bleeding within 48 h (yes/no), Thromboembolic events up to day 30 (composite: MI, ischaemic stroke/TIA, DVT, PE), Seizures up to day 30 (yes/no), Acute kidney injury (KDIGO) during index admission (any stage), All-cause mortality by day 30