Impact of Tranexamic Acid Use in Transfusion Rate in Patients with Complex kidney Stone Undergoing Percutaneous Nephrolithotomy: Randomised, Double-blind, Placebo Controlled Trial.

• Grant number: 16/04644-8
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2016
• End date: November 30, 2018
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Fabio Carvalho Vicentini
• Grantee: Fabio Carvalho Vicentini
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Carlos Alfredo Batagello ; Eduardo Mazzucchi ; Miguel Srougi ; Sabrina Thalita dos Reis Faria

Abstract

Introduction: Kidney stone is a high incidence and prevalent disease affecting people around the world. Nearly 1 in 11 individuals in the United States will be affected at some point in their lives. Furthermore, stones are likely to recur with at least 50% of individuals experiencing another stone within 10 years of the first occurrence. Moreover, the disease mainly affects the economically active segment of the population with special social and economic implications in health.Approximately 85% of stones are composed predominantly by calcium compounds and about 7% are attributed to urinary tract infections, named struvite stones, that usually develops as jagged structures called "staghorns" and can grow to be quite large, therefore complex kidney stone. However, in HCFMUSP, to be a Brazilian national reference center in lithiasis treatment, this complex stones represents about 30 percent of all renal lithiasis treated. This complex stones require so individualized and specialized treatment, with percutaneous nephrolithotomy (PCNL) to be the standard of care for this, with advantages of higher stone clearance and cost-effectiveness when compared with other treatment alternatives.However, PCNL is associated with significant morbidity such as fever, urinary infections, septicemia and bleeding that may require blood transfusion. Of these complications, bleeding is the most unpredictable and dreaded, and can lead to significant morbidity, beyond the potential risks of blood transfusions by itself.In this way, antifibrinolytic drugs, such as tranexamic acid has been shown to reduce blood loss in a variety of surgical procedures, blood transfusion rate, morbidity and mortality related to bleeding.Objectives: The main outcome measure of our study is to evaluate the impact of tranexamic acid use in blood transfusion rate in patients with complex kidney stones undergoing PCNL (number of patients receiving blood transfusions from surgery until hospital discharge). The secondary aim is evaluate blood loss by hemoglobin measure, surgical time, stone free rate and complications. Furthermore, we want to corroborate the drug safety, previously established in the medical literature.Methods: After protocol approval by the hospital´s ethics, patients undergoing PCNL by complex renal stone (GUYS classification III and IV) and who provided written informed consent, will be eligible for the trial. After the patients, eligibility confirm we will randomly allocate them to the intervention or placebo group by a computer program. Trial participants, care providers, surgeons, anesthesiology team and data collectors will be blind to group assignment. Patients will be manage with surgical standardized technique by Endourological HCFMUSP group and controlled care after surgery. Blood transfusion rate, hemoglobin drop and complications will be evaluate in 7, 30, 90 and 180 days after surgery. At first day after surgery CT scan will be perform to access stone free rate and complications. (AU)