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

Robotic-assisted Radical Prostatectomy Clinical Trial

— RARPEX  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319614
• Other study ID #: RARPEX
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Hradec Kralove
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: February 12, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Robotic-assisted Radical Prostatectomy

Intervention

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.
• Placebos
100 ml of saline will be administered in the beginning of the procedure.

Locations

Country	Name	City	State
Czechia	University Hospital Hradec Králové	Hradec Králové

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Balík M, Košina J, Hušek P, Brodák 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of blood loss	The drop of hemoglobin level, weighted on gram of prostate or creatinin level.	7 days after the procedure
Secondary	The risk of postoperative complications	The incidence and severity of postoperative complications according to Dindo/Clavien Classification.	90 days after the procedure