Safety and efficacy of intraoperative administration of intravenous tranexamic acid in transurethral resection of prostate: A double-blind,randomised,placebo-controlled trial

Abstract

Purpose:

The purpose of this article is to evaluate and compare the effect of intravenous tranexamic acid (TXA) with placebo on haemorrhage and quality of vision during and post-transurethral resection of the prostate (TURP).

Methods:

For nine months (September 2016 until June 2017), a randomised clinical trial was conducted with 70 patients, age 50–80 years, who were included in the study according to inclusion criteria (patients who required surgical intervention because of benign prostatic hyperplasia, prostate weight (<100 cc), American Society of Anesthesiologists score ⩽II, etc.) and enrolled randomly one to one in two study groups, and who underwent TURP in Shahid Beheshti Hospital of Hamadan University of Medical Sciences by a single surgeon.

Interventions:

The study group participants received 500 mg TXA in 500 ml ringer serum (concentration of 1 mg/ml, infusion rate 100 mg/min, maximum dose of 15 mg/kg), whereas the control group received only ringer serum during surgery. The results were then compared for the variables operation time, amount of haematocrit (HCT)-haemoglobin (Hb) reduction following surgery and surgeon satisfaction.

Results:

Both groups had no difference in age, weight and prostate weight. Surgeon satisfaction was evaluated at the end of the operation. The frequency of high satisfaction in case and control groups was 74.3% and 8.65%, whereas low satisfaction was 0% and 42.69%, respectively (p < 0.05). The mean time of operation was 53.57±16.43 vs 120.71±47.76 minutes in the case and control group, respectively (p < 0.05). The mean HCT-Hb decrease (p = 0.00) and the amount of infused volume before and after the operation (p = 0.03) between both groups were significantly different. None of the patients experienced TXA side effects.

Conclusions:

Intravenous TXA can prevent haemorrhage and higher Hb and HCT reduction following TURP, shortening the operation time and improving surgeon vision during TURP.

Level of evidence:

Keywords

Haemorrhage placebo RCT tranexamic acid TURP

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