Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients
Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial
Postoperative anemia is a frequent complication after total knee arthroplasty, with an incidence of 87%. Iron supplementation is known to be effective in treatment and prevention of postoperative anemia. The investigators examined the effect of intravenous iron isomaltoside (Monofer®) administration on postoperative anemia and transfusion requirements in patients undergoing total knee arthroplasty.
Participants undergoing total knee arthroplasty will be randomly assigned to treatment group or control group. After main procedure of total knee arthroplasty, iron isomaltoside 1000 (Monofer®) or normal saline will be intravenously administered depending on the group assigned. The dose of iron isomaltoside will be determined based on patient's body weight using the manufacturer's recommendation. Serum hemoglobin, hematocrit, iron, ferritin, transferrin saturation, and phosphorus level will be checked at preoperative day, postoperative day 1, 7, and 30.
The primary outcome is the incidence of postoperative anemia at 30 days after surgery. Secondary outcomes included the incidence and amount of red blood cell transfusion during admission period, hospital length of stay, the incidence of surgical site infection, and quality of life during postoperative period.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、03080
- Seoul National University Hospital
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参与标准
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 undergoing total knee arthroplasty
Exclusion Criteria:
- bilateral total knee arthroplasty
- hematochromatosis or hemosiderosis
- hemolytic anemia
- history of drug allergy
- liver cirrhosis or hepatitis
- systematic lupus erythematosus
- rheumatic arthritis
- allergic disease
- history of transfusion within one month from surgery
- parturient
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment
Patients in this group would receive Iron Isomaltoside 1000 (Monofer®) after main procedure of total knee arthroplasty.
The dose of iron isomaltoside would be determined based on the patient's body weight.
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Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
其他名称:
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无干预:Control
Patients in this group would receive 100ml of normal saline after main procedure of total knee arthroplasty.
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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 |
---|---|---|
Postoperative anemia
大体时间:30 days after surgery
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Incidence of postoperative anemia at 30 days after surgery
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30 days after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Transfusion
大体时间:During admission period for surgery, an average of 2 weeks
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Incidence and amount of red blood cell transfusion during admission
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During admission period for surgery, an average of 2 weeks
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Hemoglobin
大体时间:1 day, 7 days, and 30 days after surgery
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serum hemoglobin level (g/dL)
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1 day, 7 days, and 30 days after surgery
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Hematocrit
大体时间:1 day, 7 days, and 30 days after surgery
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Hematocrit level (%)
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1 day, 7 days, and 30 days after surgery
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Iron
大体时间:1 day, 7 days, and 30 days after surgery
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serum iron level (μg/dL)
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1 day, 7 days, and 30 days after surgery
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Ferritin
大体时间:1 day, 7 days, and 30 days after surgery
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serum ferritin level (ng/mL)
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1 day, 7 days, and 30 days after surgery
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Transferrin saturation
大体时间:1 day, 7 days, and 30 days after surgery
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Transferrin saturation (%)
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1 day, 7 days, and 30 days after surgery
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Phosphorus
大体时间:1 day, 7 days, and 30 days after surgery
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Serum phosphorus level (mg/dL)
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1 day, 7 days, and 30 days after surgery
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Surgical site infection
大体时间:During admission period for surgery, an average of 2 weeks
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Incidence of surgical site infection
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During admission period for surgery, an average of 2 weeks
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Hospital length of stay
大体时间:During admission period for surgery, an average of 2 weeks
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Hospital length of stay (days)
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During admission period for surgery, an average of 2 weeks
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Quality of life using EQ-5D
大体时间:30 days after surgery
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Assessment of quality of life during postoperative periods using EQ-5D (EuroQol-5 Dimension) questionaire
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30 days after surgery
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Quality of life using FACT-An
大体时间:30 days after surgery
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Assessment of quality of life during postoperative periods using FACT-An (The Functional Assessment of Cancer Therapy-Anemia) questionaire
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30 days after surgery
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合作者和调查者
出版物和有用的链接
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
- H-1709-079-885
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Iron Isomaltoside 1000的临床试验
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Rigshospitalet, DenmarkHvidovre University Hospital; Bispebjerg Hospital; Regionshospitalet Viborg, Skive; Gentofte Hospital 和其他合作者未知
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TaiGen Biotechnology Co., Ltd.R&G Pharma Studies Co.,Ltd.完全的
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HeadSense MedicalUniversity of Maryland, College Park未知