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

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.

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)

“…Based on the results of our pilot study, we demonstrated lower blood loss in the tranexamic acid group compared to the placebo group. The differences were statistically signi cant evaluating the decrease in hemoglobin, especially when related per gram of prostate removed (27).…”

“…Based on the literature and our pilot study (27), we decided to administer a single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline to all patients in the treatment group 1 at the beginning of procedure. In the control group 2 we administer only 100 ml saline as placebo.…”

“…According to data from our pilot study (27), we are not able to measure perioperative blood loss, because of many biases. The volume of suction uid is affected by urine coming out of open urinary tract, lymphatic secretion from damaged tissue.…”

“…The sample size calculation is based on the data from our pilot study (27). We used a Two-Sample T-Tests Allowing Unequal Variance with respect to the primary endpoint, which is the drop of hemoglobin level.…”

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

“…The sample size calculation is based on the data from our pilot study [ 29 ]. We used two-sample T tests allowing unequal variance with respect to the primary endpoint, which is the difference in hemoglobin level drop on postoperative day (POD) 1.…”