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

M Balik, J Kosina, P Husek, J Pacovsky, M Brodak, F Cecka, M Balik, J Kosina, P Husek, J Pacovsky, M Brodak, F Cecka

Abstract

Background: The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in 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/design: Based on the results of our pilot study, we decided to conduct this prospective, double-blind, randomized trial to confirm the preliminary data. The primary endpoint is to analyze the effect of tranexamic acid on perioperative and postoperative blood loss (decrease in hemoglobin levels) in robotic-assisted radical prostatectomy. The additional endpoint is to analyze the effect of tranexamic acid on postoperative complications and confirm the safety of tranexamic acid in robotic-assisted radical prostatectomy.

Discussion: No study to date has tested the prophylactic administration of tranexamic acid at the beginning of robotic-assisted radical prostatectomy. This study is designed to answer the question of whether the administration of tranexamic acid might lower the blood loss after the procedure or increase the rate and severity of complications.

Trial registration: ClinicalTrials.gov NCT04319614. Registered on 25 March 2020.

Keywords: Bleeding prophylaxis; Robotic-assisted radical prostatectomy; Tranexamic acid.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Process phases flowchart of randomized trial according to the CONSORT guidelines
Fig. 2
Fig. 2
The schedule of enrollment, interventions, and assessments of randomized trial according to the SPIRIT guidelines (t−2 = − 14 − 1 days; t−1 = − 1 day; t0 = at the beginning of the procedure; t1 = 3 h after the procedure; t2 = POD1; t3 = POD2; t4 = POD7; t5 = 3 months after the procedure ± 7 days)

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