Tranexamic Acid for Bleeding Reduction During TURP Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Total Hemoglobin Mass Recovered in Irrigation Effluent [Срок оценки: During surgery (from start of resection to end of procedure, up to 3 hours)]
• Postoperative Hemoglobin Concentration [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (5)

• Perioperative Red Blood Cell Transfusion Requirement [Срок оценки: From surgery until hospital discharge (up to 7 days)]
• Operative Duration [Срок оценки: During surgery (from skin incision to end of resection, up to 3 hours)]
• Duration of Bladder Catheterization [Срок оценки: From end of surgery until urinary catheter removal (up to 7 days)]
• Hospital Length of Stay [Срок оценки: From end of surgery until hospital discharge (up to 14 days)]
• Perioperative Adverse Events [Срок оценки: From surgery until hospital discharge (up to 30 days)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Morocco · 1 центр

• Mohammed V Military Teaching Hospital — Rabat

Идентификаторы

NCT: NCT07460518 · HMIMV-TXA-TURP-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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