Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy?

Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in patients with life expectancy for more than 10 years. In recent years, a general tendency toward minimally invasive surgical procedures has been seen. Despite tremendous development in the technology and technique of robotic-assisted radical prostatectomy for more than 25 years, there is still need to look for ways to improve oncological and functional outcomes. Decreasing peri- and postoperative blood loss may lead to faster recovery after the procedure.

Tranexamic acid is an antifibrinolytic used to relieve bleeding. The mechanism of action lies in binding to plasma free plasminogen with higher affinity than tissue plasminogen activator. It prevents its conversion to plasmin, which is responsible for the degradation of fibrin polymers. It results in greater stability of the fibrin clot at the site of bleeding and, therefore, lower blood loss. The use of tranexamic acid during or after the operation does not improve results, unlike administration prior to surgery and the dorsal complex vein is sutured in the beginning of the procedure.

This study is designed to answer the question of whether it might lower the drop in hemoglobin level after the procedure or increase the rate and severity of complications.

This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P).

Inclusion criteria

• Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
• Signed informed consent provided
• Body mass index ≤ 35
• Age of the patient ≤ 75 years
• Operating surgeon with experience > 100 cases

Exclusion criteria

• Body mass index > 35
• Age of the patient > 75 years
• Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
• Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
• Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
• Allergic reaction to tranexamic acid
• Operating surgeon with experience < 100 cases
• Participation in other study