腰椎手术中的口服和静脉氨甲环酸
腰椎手术中口服和静脉注射氨甲环酸的随机对照试验
The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.
研究概览
地位
地位
干预/治疗
干预/治疗
详细说明
Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.
The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.
研究类型
研究类型
注册 (实际的)
注册
阶段
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Health System
-
-
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
- Must be able to swallow tablets
Exclusion Criteria
- Known allergy to TXA
- History of renal failure or kidney transplant
- History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
- Placement of an arterial stent within the past year
- History of blood clots (DVT, PE) within the past year
- Refusal to receive blood products
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
有源比较器:Intravenous Tranexamic Acid
The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure. |
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
其他名称:
|
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有源比较器:Oral Tranexamic Acid
The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision. |
To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
其他名称:
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Post-operative Change in Hemoglobin Level Between the Two Groups
大体时间:Day of surgery up to 24 hours day after surgery
|
Day of surgery up to 24 hours day after surgery
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-operative Change of Blood Volume in Milliliters Between the Two Groups
大体时间:1 day after surgery until 7 days after surgery
|
The total blood volume change is calculated in milliliters |
1 day after surgery until 7 days after surgery
|
|
Number of Participants Transfused Between the Two Groups
大体时间:1 day after surgery until patient is discharged, up to 7 days
|
1 day after surgery until patient is discharged, up to 7 days
|
|
|
Number of Participants Experiencing a Thromboembolic Event Between the Two Groups
大体时间:1 day after surgery until post operative visit 4 weeks after surgery
|
1 day after surgery until post operative visit 4 weeks after surgery
|
合作者和调查者
出版物和有用的链接
一般刊物
- Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (估计的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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