drugset / Trial / NCT07460518

Tranexamic Acid for Bleeding Reduction During TURP Surgery

NCT07460518

Phase 4 Not yet recruiting 80 enrolled Hamza Najout
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Transurethral resection of the prostate (TURP) is commonly performed in elderly patients and may be associated with perioperative bleeding leading to postoperative anemia and delayed recovery. Tranexamic acid (TXA), an antifibrinolytic agent, may reduce surgical bleeding by inhibiting fibrin degradation. This prospective randomized quadruple-blind placebo-controlled clinical trial evaluates whether perioperative administration of intravenous tranexamic acid reduces intraoperative blood loss and preserves postoperative hemoglobin concentration in patients undergoing TURP under standardized spinal anesthesia. Participants are randomly assigned to receive either intravenous tranexamic acid or placebo prior to surgery. The primary outcomes assess objective measures of perioperative blood loss and postoperative hemoglobin levels. Secondary outcomes include recovery parameters, perioperative safety, and exploratory hospital-level economic impact. The study aims to determine whether anesthesia-led haemostatic optimization using tranexamic acid improves perioperative physiological stability and recovery efficiency within an enhanced recovery framework.

Timeline

Start
2026-03-15
Primary completion
2026-06-30
Completion
2026-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 10 mg/kg Intravenous