Reduction of Perioperative Blood Loss in Urethral Reconstruction Using Tranexamic Acid (REDUCER Trial): A Multicenter Pragmatic Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in hemoglobin
研究概览
简要总结
This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty. Participants will be randomly assigned to receive either a single intravenous dose of TXA at the start of anesthesia or standard care without TXA. Researchers will compare hemoglobin change after surgery as well as estimated blood loss and complications.
详细描述
Urethroplasty can be associated with variable perioperative blood loss. Tranexamic acid (TXA) is an antifibrinolytic medication that has been shown to reduce blood loss in multiple surgical settings, but it has not been well studied in urethroplasty.
This is a prospective, randomized, open-label trial evaluating the effect of a single perioperative dose of TXA in adult patients undergoing elective urethroplasty. Participants will be assigned in a 1:1 ratio to receive either TXA or standard care without TXA. TXA will be administered as a single intravenous dose at induction of anesthesia.
The primary outcome is postoperative change in hemoglobin. Secondary outcomes include estimated blood loss, operative time, transfusion requirement, and perioperative complications. Participants will be followed through the postoperative period, including routine clinical follow-up.
Study data will be collected from routine clinical care and the electronic medical record. The goal of this study is to determine whether TXA may provide a simple and practical strategy to reduce blood loss in urethroplasty.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years old)
- •Undergoing urethroplasty for urethral stricture disease
- •Ability to provide informed consent
排除标准
- •Known contraindication to tranexamic acid (TXA)
- •History of thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke)
- •Known bleeding disorder or coagulopathy
- •Current use of anticoagulation that cannot be safely held perioperatively
- •Severe renal impairment
- •Allergy or hypersensitivity to tranexamic acid
- •History of seizures
- •Inability to provide informed consent
研究组 & 干预措施
Standard of Care (No TXA)
Participants undergoing urethroplasty will receive standard surgical care without tranexamic acid.
干预措施: Urethroplasty (Procedure)
Tranexamic Acid (TXA)
Participants undergoing urethroplasty will receive tranexamic acid (TXA) administered perioperatively in addition to standard surgical care.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Change in hemoglobin
时间窗: Baseline to postoperative day 5-7
Difference between preoperative hemoglobin and postoperative hemoglobin measured as part of routine clinical care.
次要结局
- Estimated intraoperative blood loss (milliliters)(During surgery)
- Total operative time (minutes)(During surgery)
- Intraoperative surgical field quality assessed by the Boezaart Surgical Field Grading Scale(During surgery)
- 30-day postoperative complications(Within 30 days after surgery)
研究者
Amjad Alwaal, MD, MSc, FRCSC, FACS
Associate Professor of Urology
Rutgers, The State University of New Jersey