Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy. a Double-blind, Placebo-controlled Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the value of tranexamic acid
研究概览
简要总结
Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.
详细描述
To evaluate whether intravenous tranexamic acid or tranexamic acid in the irrigation fluid in percutaneous nephrolithotomy (PCNL) in reducing bleeding during and after PCNL.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient 18 years or older
- •Stones ≥ 2 cm and/or mild to moderate hydronephrosis.
排除标准
- •Age <18 years or Pregnancy
- •Bilateral simultaneous PCNL
- •Morbid obesity (BMI >40)
- •Refuse to complete study requirements
- •Untreated UTI
- •Atypical bowel interposition by CT
- •Tumour in the presumptive access tract area or Potential malignant kidney tumour
研究组 & 干预措施
tranexamic acid local
tranexamic acid inside the irrigation fluid
干预措施: Tranexamic acid injection (Drug)
tranexamic acid IV
tranexamic acid injection
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
To assess the value of tranexamic acid
时间窗: 12 months
To compare the efficacy and safety of 0.1% IV tranexamic acid versus inside the irrigant fluid tranexamic acid in reducing blood loss during PCNL. Moreover, to assess the adverse events of tranexamic acid.
次要结局
- Hemoglobin drop post PCNL.(12 months)
- Requirement of blood transfusion post PCNL.(12 months)
研究者
Diaa Eldin Taha Ramadan Mohamed
Lecturer of urology
Kafrelsheikh University