THE USE OF TRANEXAMIC ACID IN RADICAL PROSTATECTOMY

Background: The prophylactic administration of tranexamic acid has been shown to be appropriate for procedures with a high risk of perioperative bleeding in cardiac surgery and orthopaedics. In urology the ambiguous results have been reported. Our goal was to evaluate the effect of tranexamic acid administration in robotic-assisted radical prostatectomy (RARP). A pilot, prospective, double-blind, randomized study was conducted to evaluate this effect. Methods: The study included 100 patients who received RARP in the period from April 2017 to January 2018. The patients were randomly assigned to study and control groups of 50 patients each. Results: The median follow-up was 6 months. Lower haemoglobin level drop weighted for gram of operated prostate was observed in the study group when treating the dorsal vein complex (DVC) at the beginning of the procedure (p = 0.004 after 3 hours and p < 0.001 after 24 hours). There was no evidence of any serious side effect of tranexamic acid. Conclusion: We demonstrated the safety of tranexamic acid at RARP. In addition, we showed that administration of tranexamic acid at the beginning of RARP significantly reduces the decrease in haemoglobin after the procedure when treating the DVC at the beginning of the procedure.

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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)

10.21203/rs.3.rs-350770/v1 ◽

2021 ◽

Author(s):

Michal Balik ◽

Josef Kosina ◽

Petr Husek ◽

Jaroslav Pacovsky ◽

Milos Brodak ◽

...

Keyword(s):

Radical Prostatectomy ◽

Blood Loss ◽

Tranexamic Acid ◽

Postoperative Blood Loss ◽

Double Blind ◽

Robotic Assisted ◽

Prophylactic Administration ◽

End Point ◽

Perioperative Bleeding ◽

Robotic Assisted Radical Prostatectomy

Abstract 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.

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