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

NCT ID: NCT04319614

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2022-06-30

Brief 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).

Conditions

Robotic-assisted Radical Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic acid

Group Type: EXPERIMENTAL

Tranexamic Acid Injectable Product

Intervention Type: DRUG

A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.

Saline

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

Michal Balik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Milos Brodak, Prof.MD, PhD.

Role: STUDY_CHAIR

University Hospital Hradec Kralove

Michal Balik, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove

Locations

University Hospital Hradec Králové

Hradec Králové, , Czechia

Countries

Czechia

References

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.

Reference Type: BACKGROUND

PMID: 33355078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35717263 (View on PubMed)

Other Identifiers

RARPEX

Identifier Type: -

Identifier Source: org_study_id