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

Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? The RARPEX (Robotic Assisted Radical Prostatectomy With TranEXamic Acid) Study.

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.

Study Overview

• Status: Completed
• Conditions: Robotic-assisted Radical Prostatectomy
• Intervention / Treatment: Drug: Tranexamic Acid Injectable Product; Drug: Placebos

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).

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Hradec Králové, Czechia, 50005
    • University Hospital Hradec Kralove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Saline	Drug: Placebos; 100 ml of saline will be administered in the beginning of the procedure.
EXPERIMENTAL: Tranexamic acid	Drug: Tranexamic Acid Injectable Product; A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of blood loss	The drop of hemoglobin level, weighted on gram of prostate or creatinin level.	7 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The risk of postoperative complications	The incidence and severity of postoperative complications according to Dindo/Clavien Classification.	90 days after the procedure

Collaborators and Investigators

• Sponsor: University Hospital Hradec Kralove
• Investigators: Study Chair: Milos Brodak, Prof.MD, PhD., University Hospital Hradec Kralove; Principal Investigator: Michal Balik, MD, University Hospital Hradec Kralove

Publications and helpful links

General Publications

• Balik M, Kosina J, Husek P, Brodak M, Cecka F. Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study. Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.
• Balik M, Kosina J, Husek P, Pacovsky J, Brodak M, Cecka F. 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. Trials. 2022 Jun 18;23(1):508. doi: 10.1186/s13063-022-06447-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2020
• Primary Completion (ACTUAL): February 12, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Tranexamic acid; robotic assisted radical prostatectomy; bleeding prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: RARPEX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No