Tranexamic Acid for Perioperative Haemostatic Optimisation During Transurethral Resection of the Prostate: A Randomized Quadruple-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total Hemoglobin Mass Recovered in Irrigation Effluent
研究概览
简要总结
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.
详细描述
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:
- total haemoglobin mass recovered in irrigation effluent as an objective measure of intraoperative blood loss, and
- postoperative haemoglobin concentration measured at 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple-blind design including participants, care providers, investigators, and outcome assessors. Study medication preparation ensured identical appearance of tranexamic acid and placebo solutions.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tranexamic Acid (Drug)
Placebo Group
Participants receive an identical volume of normal saline placebo administered intravenously prior to surgery under standardized spinal anesthesia.
干预措施: Placebo (Normal Saline) (Drug)
结局指标
主要结局
Total Hemoglobin Mass Recovered in Irrigation Effluent
时间窗: During surgery (from start of resection to end of procedure, up to 3 hours)
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
时间窗: 24 hours after surgery
Systemic hemoglobin concentration (g/dL) measured 24 hours after transurethral resection of the prostate to assess perioperative hemoglobin preservation.
次要结局
- Perioperative Red Blood Cell Transfusion Requirement(From surgery until hospital discharge (up to 7 days))
- Operative Duration(During surgery (from skin incision to end of resection, up to 3 hours))
- Duration of Bladder Catheterization(From end of surgery until urinary catheter removal (up to 7 days))
- Hospital Length of Stay(From end of surgery until hospital discharge (up to 14 days))
- Perioperative Adverse Events(From surgery until hospital discharge (up to 30 days))
研究者
Hamza Najout
Assistant Professor of Anesthesiology and Intensive Care
Military Teaching Hospital Mohammed V