PD01-04 IMPACT OF INTRAOPERATIVE USE OF TRANEXAMIC ACID IN PATIENTS WITH COMPLEX KIDNEY STONES UNDERGOING PERCUTANEOUS NEPHROLITHOTOMY: PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL.

Abstract

INTRODUCTION AND OBJECTIVE: Bleeding is one of the most unpredictable and threatening complication during PCNL. Tranexamic acid (TXA), an antifibrinolytic agent, has proven to reduce blood loss and mortality in trauma and elective surgeries. We aimed to evaluate the impact of intraoperative use of TXA on PCNL transfusion rate, blood loss and effectiveness. METHODS: We conducted a single‐center, double‐blinded, randomized, placebo controlled trial, from May 2016 to June 2019. Eligible participants were adult stone formers with complex stones (Guy's 3 and 4). Participants were registered prospectively and randomized in a 1:1 ratio. Intervention group received 1g of TXA at anesthesia induction. The control group received placebo. The main outcome measure was perioperative blood transfusion rate. The secondary outcome included hemoglobin drop, complications and stonefree rate (SFR). Patient, surgeon and anesthesiology team were blinded to intervention assignment. The intention‐to‐treat analyses was employed. Data were securely stored electronically using REDCap™. ClinicalTrials.gov identifier NCT02966236. RESULTS: A total of 192 subjects were included in the study. The recruitment rate was 100% and 97.9% completed the study. Treatment groups were balanced with respect to baseline patient demographics, stone features and operative parameters. Transfusion rate was lower in the TXA group compared to placebo (2.2% vs. 9.5%; p= 0.032). Post‐hoc analysis demonstrated that hemoglobin concentrations at 3 moments after surgery (at the end of surgery, 12h, and 24h) were statistically higher in the intervention group compared to placebo (Fig1). TXA group had shortened time to 75% hemoglobin recovery estimated by a non‐linear regression and bootstrap method (Fig1). SFR was statistically higher in the TXA group (p=0.04). No adverse reaction was reported and no differences regarding complications between groups. CONCLUSIONS: The intraoperative use of TXA during PCNL for complex stones is safe and effective in reducing perioperative blood loss and transfusion rate. Moreover, TXA use contributes to better stone clearance than placebo without increasing complications.