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Effect of tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomized, double-blinded, placebo-controlled trial

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Author(s):
Carlos Alfredo Batagello
Total Authors: 1
Document type: Doctoral Thesis
Press: São Paulo.
Institution: Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD)
Defense date:
Examining board members:
Fabio Carvalho Vicentini; Eduardo Mazzucchi; Renato Nardi Pedro
Advisor: Fabio Carvalho Vicentini
Abstract

Introduction: Percutaneous nephrolithotomy (PCNL) is the first-line therapy for patients presenting with complex kidney stones. Although technology and surgical techniques have advanced, the need for blood transfusion remains one of the most common complication during PCNL. The overall blood transfusion rate was 5.7%. However, when patients were stratified according to their stone complexity, up to 22% of patients with staghorn stones required blood transfusion. Recent randomized trials have reported that the use of tranexamic acid, a synthetic antifibrinolytic agent, reduced surgical bleeding and consequently the need for blood transfusion in elective surgery and trauma. Nevertheless, to date, few studies have investigated the role of intravenous administration of tranexamic acid in PCNL and conflicting results have been reported. Objectives: To assess the efficacy and safety of single-dose tranexamic acid on the blood transfusion rate of patients with complex kidney stones who have undergone PCNL. In addition, we aimed to evaluate the hemoglobin drop, operative time, stone-free rate (SFR), and complications of patients with complex kidney stones undergone PCNL. Material and methods: In a randomized, double-blinded, placebo-controlled trial, 192 patients with complex kidney stone (Guys Stone Scores III-IV) were prospectively enrolled and randomized (1:1 ratio) to receive either one dose of tranexamic acid (1 g) or a placebo at the time of anesthetic induction for PCNL. Stone clearance was evaluated by a abdominal non-contrasted computed tomography (NCCT) performed on postoperative day (POD) 1. Complications were graded according to the Clavien-Dindo score. 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): 0.030.76; P = 0.033, number-needed-to-treat: 12). Patients randomized to the tranexamic acid group showed higher immediate and three-month SFR compared with those in the placebo group (29% vs 14.7%, odds ratio [95% CI]: 2.37 [1.15-4.87], P = 0.019, and 46.2% vs 28.1%, odds ratio [95% CI]: 2.20 [1.20-4.02], P = 0.011, respectively). Faster hemoglobin recovery was demonstrated by patients in the tranexamic group (21.3 [11.5 - 31.2] vs. 46.8 [35.1 - 58.4], 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 hemoglobin recovery without increasing complications. A single dose of tranexamic acid at the time of anesthetic induction could be considered standard clinical practice for patients with complex kidney stones undergoing PCNL (AU)

FAPESP's process: 16/24508-1 - Impact of tranexamic acid use in transfusion rate in patients with complex kidney stone undergoing percutaneous nephrolithotomy: randomised, double-blind, placebo controlled trial
Grantee:Carlos Alfredo Batagello
Support Opportunities: Scholarships in Brazil - Doctorate (Direct)