SNPMiner Trials by Shray Alag

SNPMiner SNPMiner Trials (Home Page)

Report for Clinical Trial NCT04319614

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

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 December 2021. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.

NCT04319614 Robotic-assisted Radical Prostatectomy

2 Interventions

Name: Tranexamic Acid Injectable Product

Description: A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.
Type: Drug
Group Labels: 1

Tranexamic acid

Name: Placebos

Description: 100 ml of saline will be administered in the beginning of the procedure.
Type: Drug
Group Labels: 1


Primary Outcomes

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

Measure: Reduction of blood loss

Time: 7 days after the procedure

Secondary Outcomes

Description: The incidence and severity of postoperative complications according to Dindo/Clavien Classification.

Measure: The risk of postoperative complications

Time: 90 days after the procedure

Purpose: Prevention

Allocation: Randomized

Parallel Assignment

There is one SNP


1 I90P

This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P). --- I90P ---

HPO Nodes