NCT07460518 Tranexamic Acid for Bleeding Reduction During TURP Surgery
| NCT ID | NCT07460518 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hamza Najout |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-03-30 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2026-03-30 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Provided written informed consent Exclusion Criteria: * 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 * Current anticoagulant therapy not appropriately discontinued * History of seizure disorder * Refusal to participate
Frequently Asked Questions
Who can join the NCT07460518 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07460518 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07460518 currently recruiting?
Yes, NCT07460518 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hamza Najout to inquire about joining.
Where is the NCT07460518 trial being conducted?
This trial is being conducted at Rabat, Morocco.
Who is sponsoring the NCT07460518 clinical trial?
NCT07460518 is sponsored by Hamza Najout. The trial plans to enroll 80 participants.