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.
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
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
Parallel
Tranexamic Acid
DrugIntravenous tranexamic acid administered at a dose of 10 mg/kg approximately 30 minutes before surgical resection to reduce perioperative bleeding during transurethral resection of the prostate.
Placebo (Normal Saline)
DrugIntravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.
Total Hemoglobin Mass Recovered in Irrigation Effluent
Total hemoglobin mass (grams) quantified from irrigation effluent collected during transurethral resection of the prostate as an objective measure of intraoperative blood loss.
Postoperative Hemoglobin Concentration
Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.
Perioperative Red Blood Cell Transfusion Requirement
Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds.
Operative Duration
Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion.
Duration of Bladder Catheterization
Number of days from surgery until removal of urinary bladder catheter.
Hospital Length of Stay
Total number of days from surgery to hospital discharge.
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Hamza Najout
Lead sponsor
Military Teaching Hospital Mohammed V
Sponsor institution
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