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临床试验/NCT03470649
NCT03470649已完成不适用

Effect of Intravenous Iron Isomaltoside on Postoperative Anemia in Patients Underwent Total Knee Arthroplasty: A Single-blind Randomized Controlled Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Postoperative anemia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients undergoing total knee arthroplasty

排除标准

  • 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

研究组 & 干预措施

Treatment

Experimental

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.

干预措施: Iron Isomaltoside 1000 (Drug)

结局指标

主要结局

Postoperative anemia

时间窗: 30 days after surgery

Incidence of postoperative anemia at 30 days after surgery

次要结局

  • Transfusion(During admission period for surgery, an average of 2 weeks)
  • Ferritin(1 day, 7 days, and 30 days after surgery)
  • Transferrin saturation(1 day, 7 days, and 30 days after surgery)
  • Hemoglobin(1 day, 7 days, and 30 days after surgery)
  • Hematocrit(1 day, 7 days, and 30 days after surgery)
  • Iron(1 day, 7 days, and 30 days after surgery)
  • Phosphorus(1 day, 7 days, and 30 days after surgery)
  • Surgical site infection(During admission period for surgery, an average of 2 weeks)
  • Hospital length of stay(During admission period for surgery, an average of 2 weeks)
  • Quality of life using EQ-5D(30 days after surgery)
  • Quality of life using FACT-An(30 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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