drugset / Trial / NCT04319614

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

NCT04319614 ↗

Phase 4 Completed 200 enrolled University Hospital Hradec Kralove
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 20 mg/kg —

Indications

No indication recorded.