Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomised, double‐blinded, placebo‐controlled trial

Objectives To assess the efficacy and safety of single‐dose tranexamic acid on the blood transfusion rate and outcomes of patients with complex kidney stones undergoing percutaneous nephrolithotomy (PCNL). Patients and Methods In a randomised, double‐blinded, placebo‐controlled trial, 192 patients with complex kidney stone (Guy’s Stone Scores III–IV) were prospectively enrolled and randomised (1:1 ratio) to receive either one dose of tranexamic acid (1 g) or a placebo at the time of anaesthetic induction for PCNL. The primary outcome measure was the occurrence rate of perioperative blood transfusion. The secondary outcome measures included blood loss, operative time, stone‐free rate (SFR), and complications. ClinicalTrials.gov identifier: NCT02966236. Results The overall risk of receiving a blood transfusion was reduced in the tranexamic acid group (2.2% vs 10.4%; relative risk, 0.21, 95% confidence interval [CI] 0.03–0.76, P = 0.033; number‐needed‐to‐treat: 12). Patients randomised to the tranexamic acid group had a higher immediate and 3‐month SFR compared with those in the placebo group (29% vs 14.7%, odds ratio [OR] 2.37, 95% CI 1.15–4.87, P = 0.019, and 46.2% vs 28.1%, OR 2.20, 95% CI 1.20–4.02, P = 0.011, respectively). Faster haemoglobin recovery occurred in patients in the tranexamic acid group (mean, 21.3 days; P = 0.001). No statistical differences were found in operative time and complications between groups. Conclusions Tranexamic acid administration is safe and reduces the need for blood transfusion by five‐times in patients with complex kidney stones undergoing PCNL. Moreover, tranexamic acid may contribute to better stone clearance rate and faster haemoglobin recovery without increasing complications. A single dose of tranexamic acid at the time of anaesthetic induction could be considered standard clinical practice for patients with complex kidney stones undergoing PCNL.