Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study

Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.

Abstract

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.

Keywords: prostate carcinoma; robotic-assisted radical prostatectomy; tranexamic acid.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Blood Loss, Surgical / prevention & control*
  • Double-Blind Method
  • Fibrinolytic Agents / administration & dosage*
  • Humans
  • Male
  • Middle Aged
  • Pilot Projects
  • Prospective Studies
  • Prostatectomy / methods*
  • Robotic Surgical Procedures / methods*
  • Tranexamic Acid / administration & dosage*

Substances

  • Fibrinolytic Agents
  • Tranexamic Acid