Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy?
Condition: Robotic-assisted Radical Prostatectomy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The prophylactic administration of tranexamic acid reduces blood loss during procedures at
      high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and
      orthopedics confirm this finding. The aim of this study is to evaluate the effect of
      tranexamic acid on peri-and postoperative blood loss and incidence and severity of
      postoperative complications. A prospective, double-blind, randomized study is conducted to
      evaluate the effect on several parameters.

      Based on pilot study data the investigators decided to include 200 patients in the period
      from February 2020 to March 2022. The patients will be randomly assigned to study and control
      groups of 100 patients each. The minimum follow-up will be 3 months.
    

Detailed description: 
      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).
    

Intervention name(s): Tranexamic Acid Injectable Product; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.; 100 ml of saline will be administered in the beginning of the procedure.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tranexamic acid; robotic assisted radical prostatectomy; bleeding prophylaxis