Disorders of haemostasis are often associated with prostate surgery, with the risk of bleeding being related to systemic and local activation of fibrinolysis. Tranexamic acid exerts an antifibrinolytic action and is the standard treatment used to reduce the rate of perioperative transfusion in cardiac surgery. Its efficacy has not yet been shown in urological surgery. This RCT was therefore conducted to assess its efficacy in reducing the rate of blood transfusion in patients undergoing open radical prostatectomy and also long term safety.

The study involved 200 patients at a university hospital in Milan undergoing radical retropubic prostatectomy, who were randomised to an IV infusion of tranexamic acid (loading dose 500mg 20 minutes before surgery followed by continuous infusion at 250 mg/hour) during surgery, or equivalent volume of placebo (saline). The primary outcome was the number of patients receiving blood transfusions perioperatively and the secondary outcome was intraoperative blood loss and 6 month follow-up to assess mortality and thromboembolic events.

The following findings were reported:

• 34 (34%) patients in the tranexamic acid group were transfused vs. 55 (55%) in the control group (absolute reduction in transfusion rate 21%).

• The relative risk of receiving transfusions for patients treated with tranexamic acid was 0.62 (0.45 to 0.85); number needed to treat 5 (3 to 14); p=0.004

• At follow-up, no patients died and the occurrence of thromboembolic events did not differ between the two groups.

The researchers conclude from these findings that “intraoperative treatment with low dose tranexamic acid is safe and effective in reducing the rate of perioperative blood transfusions in patients undergoing radical retropubic prostatectomy.”