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

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Hradec Kralove
• Treatments: Tranexamic Acid

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