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

NCT04319614 | Completed Phase 4

• 1 other identifier: RARPEX
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Robotic-assisted Radical Prostatectomy

Keywords

Tranexamic acid; robotic assisted radical prostatectomy; bleeding prophylaxis

Outcome Measures

Primary Outcomes (1)

• Reduction of blood loss

  The drop of hemoglobin level, weighted on gram of prostate or creatinin level.

  7 days after the procedure

Secondary Outcomes (1)

• The risk of postoperative complications

  90 days after the procedure

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Drug: Tranexamic Acid Injectable Product

Saline

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Tranexamic Acid Injectable Product DRUG

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

Tranexamic acid

Placebos DRUG

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

Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Patients with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

Related Publications (2)

• 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.

  PMID: 33355078 BACKGROUND

• 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.

  PMID: 35717263 BACKGROUND

Study Officials

• Milos Brodak, Prof.MD, PhD.

  University Hospital Hradec Kralove

  STUDY CHAIR

• Michal Balik, MD

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: February 24, 2020
• Primary Completion: February 12, 2022
• Study Completion: June 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)