Study on the effects of Tranexamic Acid on death and the need for blood during surgery in children operated on for Brain Tumors

INTERVENTION: D02.241.223.268.860 For the intervention group, after anesthesia and before the beginning of the operative time, the patients will receive an initial dose of 15mg/kg of tranexamic acid, diluted in saline solution (0.9%) of 1ml/kg, through of a 15‐minute infusion pump. Then, an infusion of 10mg/kg/h will be administered. The solution will be prepared in such a way that the anesthetist, surgeon, patient and other healthcare professionals will not know which solution is being offered. The patients included will be randomized, in a ratio of 1:1, electronically through the REDcap software, in a random and secret way, constituting an intervention group, to receive Tranexamic Acid, and a control group, to receive saline solution. Sample Calculation: Considering our institutional history in the last 2 years, with patients with the same characteristics indicated in the inclusion and exclusion criteria, we identified a transfusion rate of 21%, thus considering a possible reduction of 52% in the transfusion rate according to what was found with previous studies in the pediatric population, the sample will be defined more precisely based on this and on a sampling formula n= Kx[P0(1‐P0)+P1(1‐P1)]/(P0‐P1)2, where is P0 is the rate of primary events in the institution's historical sample, P1 is the expected proportion in the sample of patients undergoing the intervention in which a reduction of at least 52% in the frequency of the primary outcome is expected to be identified, and K is a constant that depends on of a and statistical power, which will be established as a = 5%, and of the power of the 1‐ß test, which will be established as ß=20%, such that K=7,834,35. Thus, considering that the transfusion rate of packed red blood cells in the last two years was 21%, since 20 patients out of a total of 95 CONDITION: C23.550.505 Neoplasms of the Central Nervous System; Surgical Bleeding PRIMARY OUTCOME: Expect to find in this study the reduction of mortality and perioperative transfusion through the use of tranexamic acid in surgery of children with tumors of the central nervous system SECONDARY OUTCOME: Expect to find a reduction in intraoperative bleeding with the use of tranexamic acid in children undergoing resection of central nervous system tumors. Expect to find a reduction in the use of intraoperative vasoactive drugs with the use of tranexamic acid in children undergoing resection of central nervous system tumors We will observe the safety of the use of tranexamic acid through the surveillance of events such as seizures and thromboembolism in the first 7 postoperative days or until hospital discharge INCLUSION CRITERIA: Patients from both genders; younger than 18 years old with a diagnosis of central nervous system tumor, characterized by radiological imaging (tomography or magnetic resonance imaging); whether it's their first surgery or reoperation due to relapse or progression; preoperative hemoglobin greater than 10mg/dl