Presentation Authors: Carlos Alfredo Batagello*, Fabio Carvalho Vicentini, Sao Paulo, Brazil, Manoj Monga, Cleveland, OH, Giovani Scala Marchini, Fabio Cesar Miranda Torricelli, Alexandre Danilovic, Miguel Srougi, Willian Carlos Nahas, Eduardo Mazzucchi, Sao Paulo, Brazil
Introduction: 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 August 2018. Eligible participants were adult stone formers with complex stones (Guyâ€™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 stone-free 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 REDCapTM software. ClinicalTrials.gov identifier NCT02966236.
Results: A total of 128 subjects were included in the study. The recruitment rate was 100% and 98.4% completed the study. Treatment groups were balanced with respect to baseline patient demographics, stone features and operative parameters. The lower transfusion rate in TXA group demonstrated a trend toward significance compared to placebo (3.2% vs. 11%; p=0.08). 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). The volume of intravenous fluids and operative time were similar in both groups. SFR was statistically higher in the TXA group (p=0.01). No adverse reaction was reported. During the 30day follow-up period, we recorded one thromboembolic event, restricted to the TXA group.
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.
Source of Funding: FAPESP