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
Sponsors and collaborators
Hamza Najout
Lead sponsor
Military Teaching Hospital Mohammed V
Sponsor institution