Tranexamic Acid for Bleeding Reduction During TURP Surgery

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorHamza Najout

About this trial

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.

Eligibility criteria

Qualifiers

Male patients aged 50 years or older

Diagnosed with benign prostatic hyperplasia (BPH)

Scheduled for elective transurethral resection of the prostate (TURP) under spinal anesthesia

American Society of Anesthesiologists (ASA) physical status I-III

Disqualifiers

History of thromboembolic disease (deep vein thrombosis, pulmonary embolism, stroke)

Known hypersensitivity to tranexamic acid

Severe renal impairment (creatinine clearance <30 mL/min)

Coagulation disorders

Trial design

Treatments tested in this trial

  • Tranexamic Acid
  • Placebo (Normal Saline)

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hamza Najout

Lead sponsor

Military Teaching Hospital Mohammed V

Sponsor institution