Safety and Efficacy of Intravenous Tranexamic Acid in Reducing Blood Transfusion After Endoscopic Transurethral Resections in Urology: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Number of red blood cell transfusions
研究概览
简要总结
Transurethral resection of the prostate (TURP) represents the gold standard in the operative management of benign prostatic hyperplasia (BPH) and the transurethral resection of bladder tumor (TURBT) is the first-line surgical treatment for bladder tumors. One of the most important complications of urological endoscopic resections is intraoperative and postoperative bleeding requiring blood transfusion. Allogeneic blood transfusion is not free of risks, like infection transmission, hemolytic reactions, transfusion-related lung injury, fluid overload, increased costs and hospital length of stay.
Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA has been used to reduce blood loss and the need for allogeneic blood transfusion in cardiac surgery and orthopedic surgical procedures but few studies have assessed the efficacy of this antifibrinolytic agent in urological endoscopic procedures.
The investigators designed this double-blind, placebo controlled study evaluate the safety and efficacy of the antifibrinolytic agent tranexamic acid in reducing blood transfusion in patients undergoing endoscopic surgery in urology.
详细描述
Participants will be randomized into one of two study groups: Group TXA: intravenous tranexamic acid: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The study drug was prepared by an anesthesiologist not involved in the patient management and data collection. The anesthetic technique will be standardized. Serum hemoglobin was measured before and after surgery. The volume of the irrigation fluid, resected prostate weight and duration of resection were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>/=18)
- •male or female
- •Undergoing elective TURP or TURBT
- •Spinal anesthesia
- •Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
排除标准
- •Atrial fibrillation
- •Coronary artery disease treated with drug eluting stent
- •Severe chronic renal failure
- •Congenital or acquired thrombophilia
- •Known or suspected allergy to tranexamic acid.
研究组 & 干预措施
Tranexamic Acid
Tranexamic Acid (TXA): bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively
干预措施: Tranexamic Acid (Drug)
Placebo
An equal volume of saline
干预措施: Placebo (Drug)
结局指标
主要结局
Number of red blood cell transfusions
时间窗: From surgery until 72 hours postoperatively
次要结局
- The difference in preoperative and postoperative hematocrit levels to estimate blood loss.(the first postoperative day)
- Episodes of acute urinary retention(the first postoperative day)
- Postoperative bleeding with clot retention(the first postoperative day)
- Episodes of bladder tamponade requiring evacuation or reintervention(the first postoperative day)
- Postoperative myocardial ischemia assessed by cardiac troponin I(the first postoperative day)
研究者
Ali JENDOUBI
MD, Assistant Professor
University Tunis El Manar