Tranexamic Acid for Bleeding Reduction During TURP Surgery (TXA-TURP)

Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Perioperative Bleeding; Transurethral Resection of the Prostate; Anemia, Postoperative
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Placebo (Normal Saline)

Detailed Description

This investigator-initiated, prospective, randomized, quadruple-blind, placebo-controlled clinical trial is conducted at Mohammed V Military Teaching Hospital, Rabat, Morocco.

The study evaluates tranexamic acid as a perioperative blood management intervention during transurethral resection of the prostate performed under standardized spinal anesthesia within an enhanced recovery pathway. TURP surgery is characterized by local fibrinolytic activation that may contribute to continuous microvascular bleeding. Tranexamic acid inhibits plasminogen activation and may therefore reduce intraoperative haemoglobin loss.

Eligible participants undergoing elective TURP are randomized in a 1:1 ratio to receive either intravenous tranexamic acid (10 mg/kg) administered prior to surgical resection or placebo. Allocation concealment and quadruple blinding include participants, care providers, investigators, and outcome assessors.

The study includes two complementary co-primary haemostatic endpoints:

1. total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and
2. postoperative haemoglobin concentration measured at 24 hours.

Secondary outcomes evaluate perioperative recovery variables, transfusion requirement, hospital length of stay, adverse events, and exploratory health-economic impact from a hospital perspective.

A prespecified interim analysis evaluates feasibility, treatment effect estimation, and safety signals without early stopping rules. Final confirmatory analysis will be performed after completion of planned enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Morocco
  • Rabat
    • Rabat, Rabat, Morocco, 10180
      • Mohammed V Military Teaching Hospital
      • Contact: Hamza Najout, MD, PhD; Phone Number: +212672188155; Email: hamza.najout@gmail.com
      • Principal Investigator: hamza najout, MD, PhD(c)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid Group; Participants receive intravenous tranexamic acid (10 mg/kg) administered approximately 30 minutes before transurethral resection of the prostate under standardized spinal anesthesia.	Drug: Tranexamic Acid; Intravenous 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 Comparator: Placebo Group; Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.	Drug: Placebo (Normal Saline); Intravenous administration of normal saline placebo prepared to be identical in appearance and volume to the tranexamic acid solution to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During surgery (from start of resection to end of procedure, up to 3 hours)
Postoperative Hemoglobin Concentration	Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Red Blood Cell Transfusion Requirement	Requirement for allogeneic red blood cell transfusion during the perioperative period according to institutional transfusion thresholds.	From surgery until hospital discharge (up to 7 days)
Operative Duration	Total duration of transurethral resection of the prostate measured in minutes from surgical start to completion.	During surgery (from skin incision to end of resection, up to 3 hours)
Duration of Bladder Catheterization	Number of days from surgery until removal of urinary bladder catheter.	From end of surgery until urinary catheter removal (up to 7 days)
Hospital Length of Stay	Total number of days from surgery to hospital discharge.	From end of surgery until hospital discharge (up to 14 days)
Perioperative Adverse Events	Occurrence of thromboembolic complications, seizures, or other serious adverse events during the perioperative period.	From surgery until hospital discharge (up to 30 days)

Collaborators and Investigators

• Sponsor: Hamza Najout

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Hemostasis; Enhanced Recovery After Surgery; Perioperative Medicine; Tranexamic Acid; Spinal Anesthesia; Patient Blood Management; TURP
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Prostatic Hyperplasia; Anemia; Organic Chemicals; Pharmaceutical Preparations; Carboxylic Acids; Crystalloid Solutions; Isotonic Solutions; Solutions; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid; Saline Solution
• Other Study ID Numbers: HMIMV-TXA-TURP-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No