Combined Intravenous and Irrigation Tranexamic Acid During Percutaneous Nephrolithotomy
The Role of Tranexamic Acid Combined Dose Intravenous and in Irrigation Fluid in Optimizing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled and Double-blind Study
Percutaneous nephrolithotomy is a minimally invasive surgical procedure used to remove large kidney stones. Although it is an effective treatment, bleeding during and after the procedure remains one of the main concerns and may sometimes require blood transfusion.
Tranexamic acid is a medication that helps reduce bleeding by limiting the breakdown of blood clots. It can be given through a vein and may also be used locally in irrigation fluid during surgery. This study evaluates whether using tranexamic acid by both routes during percutaneous nephrolithotomy can reduce blood loss, improve the clarity of the surgical field during endoscopy, and reduce the need for blood transfusion.
The study included adult patients with kidney stones larger than two centimeters who were suitable for percutaneous nephrolithotomy. Patients were randomly assigned to receive either tranexamic acid through a vein and in the irrigation fluid, or normal saline as a control treatment. Blood loss was assessed using hemoglobin and hematocrit levels before and after surgery, as well as hemoglobin concentration in the irrigation fluid collected at the end of the operation. The surgeon also assessed the clarity of the surgical field using a ten-point visual scale.
The hypothesis of the study is that combined intravenous and local administration of tranexamic acid in irrigation fluid during percutaneous nephrolithotomy reduces blood loss, improves surgical visibility, and lowers the need for blood transfusion compared with normal saline.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Qalyubia Governorate
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Banhā、Qalyubia Governorate、埃及、13511
- Benha University Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adult patients aged 18 to 70 years.
- Patients with renal stones larger than 2 centimeters.
- Patients scheduled for percutaneous nephrolithotomy.
- Normal renal function, defined as serum creatinine less than or equal to 1.5 milligrams per deciliter.
- American Society of Anesthesiologists physical status class 1 or 2.
Exclusion Criteria:
- Hypersensitivity to tranexamic acid.
- Pregnancy.
- Current anticoagulation therapy.
- Untreated urinary tract infection or urosepsis.
- Renal anatomical anomalies, including ectopic kidney, duplex collecting system, or horseshoe kidney.
- Solitary functioning kidney.
- Decompensated coagulopathy or known hematological disease.
- Acute or chronic renal disease.
- History of cerebrovascular events or thromboembolism.
- Uncontrolled arrhythmia.
- Morbid obesity.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Combined Tranexamic Acid Group
Participants in this arm received tranexamic acid 10 milligrams per kilogram intravenously in 250 milliliters normal saline 15 minutes before induction of anesthesia, in addition to the same dose of tranexamic acid added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
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Tranexamic acid was administered as a combined intravenous and local intervention during percutaneous nephrolithotomy.
The intravenous dose was given before anesthesia induction, and the local dose was added to the initial irrigation fluid used during the procedure.
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安慰剂比较：Normal Saline Control Group
Participants in this arm received 250 milliliters normal saline intravenously 15 minutes before induction of anesthesia, in addition to normal saline placebo added to the first 4 liters of irrigation fluid during percutaneous nephrolithotomy.
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Normal saline was used as the placebo comparator.
It was administered intravenously before anesthesia induction and added to the initial irrigation fluid during percutaneous nephrolithotomy.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in hemoglobin concentration after percutaneous nephrolithotomy
大体时间：Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hemoglobin concentration measured before surgery and after surgery to assess perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in hematocrit concentration after percutaneous nephrolithotomy
大体时间：Preoperative, immediate postoperative, and 24 hours postoperative
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Difference in hematocrit concentration measured before surgery and after surgery as an additional indicator of perioperative blood loss.
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Preoperative, immediate postoperative, and 24 hours postoperative
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Need for blood transfusion
大体时间：Intraoperatively and up to 24 hours postoperatively
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Number of participants who required blood transfusion during the intraoperative or postoperative hospital stay period.
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Intraoperatively and up to 24 hours postoperatively
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Hemoglobin concentration in irrigation fluid
大体时间：At the end of surgery
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Hemoglobin concentration measured in the irrigation fluid collected at the end of surgery as an estimate of intraoperative blood loss.
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At the end of surgery
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Endoscopic surgical field visibility score
大体时间：At the end of surgery
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Surgical field visibility was assessed by the operating surgeon using a 10-point visual scale.
The score ranges from 1 to 10, where 1 indicates very poor visibility and 10 indicates perfect visibility.
Higher scores indicate better endoscopic surgical field visibility.
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At the end of surgery
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Postoperative Hematuria
大体时间：Up to 24 hours postoperatively
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Number of participants who developed visible blood-stained urine after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Need for Additional Hemostatic Intervention
大体时间：Up to 24 hours postoperatively
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Number of participants who required an additional intervention to control bleeding after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Infection
大体时间：Up to 24 hours postoperatively
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Number of participants who developed postoperative infection after percutaneous nephrolithotomy.
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Up to 24 hours postoperatively
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Postoperative Hematuria
大体时间：Up to 24 hours postoperatively
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Number of participants with visible hematuria requiring continued nephrostomy tube closure or delayed nephrostomy tube removal.
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Up to 24 hours postoperatively
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MS 33-5-2025
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IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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