Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic assisted radical prostatectomy? RARPEX (Robotic Assisted Radical Prostatectomy with TranEXamic acid): study protocol for a randomized controlled trial (SPIRIT Compliant)

Abstract

\n BackgroundThe prophylactic administration of tranexamic acid reduces the blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirmed this finding. The aim of this prospective, double-blind, randomized study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and on the incidence and severity of complications.Methods / DesignBased on the results of our pilot study, we decided to conduct this prospective, double-blind, randomized trial to confirm preliminary data. The primary end-point is to analyze the effect of tranexamic acid on perioperative and postoperative blood loss (decrease in hemoglobin levels) in robotic-assisted radical prostatectomy. The secondary end-point is to analyze the effect of tranexamic acid on postoperative complications. Additional end-point is to confirm the safety of tranexamic acid in robotic assisted radical prostatectomy.DiscussionNo study to date has tested the prophylactic administration of tranexamic acid in the beginning of robotic assisted radical prostatectomy. This study is designed to answer the question whether it might lower the blood loss after the procedure or increase the rate and severity of complications.Trial registrationThe trial was prospectively registered under title Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? (RARPEX) on 25th March 2020 at ClinicalTrials.gov with the registration number NCT04319614.