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

NCT04319614 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-11-09

No results posted yet for this study

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

Interventions

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.

DRUG

Placebos

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

Sponsors & Collaborators

  • University Hospital Hradec Kralove

    lead OTHER

Principal Investigators

  • Milos Brodak, Prof.MD, PhD. · University Hospital Hradec Kralove

  • Michal Balik, MD · University Hospital Hradec Kralove

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2022-02-12
Completion
2022-06-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04319614 on ClinicalTrials.gov