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临床试验/NCT01012063
NCT01012063已完成不适用

Perioperative Intravenous Iron With Erythropoietin for the Prevention of Postoperative Severe Anemia and Reduction of Transfusion in Bilateral Total Knee Replacement Arthroplasty

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2008年8月最近更新:
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
54
试验地点
1
主要终点
postoperative hemoglobin

研究概览

简要总结

The object of this study is to evaluate whether low dose intravenous iron and erythropoietin (Epo) can decrease transfusion requirement after the bilateral TKRA.

详细描述

Total knee replacement arthroplasty (TKRA) in severe osteoarthritis usually requires extensive soft tissue and bone dissection associated with substantial bleeding. Because TKRA is performed with a pneumatic tourniquet, intraoperative bleeding is not substantial, however, over 80% of the total blood loss occurs within the first 24 hour after the operation and the hidden blood loss is 50% of the total loss, making the true blood loss twice. Consequently, many patients can become anemic at early postoperative period and this anemic condition may lead to overall physical deterioration which include fatigue, dizziness, reduced exercise tolerance and delayed recovery.

Therefore, many patients frequently received the autologous or allogenic blood transfusion. In order to reduce the allogenic blood transfusion (ABT), various methods have been used, such as preoperative autologous blood donation (PABD), use of pharmacologic agents, iron or erythropoietin (Epo) and postoperative blood salvage. All of the above methods have been proved to reduce the ABT effectively6, without increase in cost.

Iron and Epo have been used widely in a variety of clinical situations instead of allogenic RBC transfusion. They also have been used for augmenting PABD or improving preoperative hemoglobin (Hb) level. However, there still remains a controversy about the efficacy of the method on the postoperative anemia. We think that these various results may be related with individual iron state of the patients and dose of drug or timing of drug application.

In this trial, iron and Epo are planned to be administered to the iron deficient non anemic patients during the operation and once again after surgery.

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
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients undergoing bilateral total knee replacement arthroplasty
  • American society of anesthesiologist class 1-3
  • Hb>100 g/L
  • Either serum ferritin<100 ng/ml or 100<ferritin<300 ng/ml with a transferrin saturation (TSAT) <20%

排除标准

  • Hematologic disease
  • Thromboembolic disease
  • Hepatic or renal disease
  • Coagulation disorder
  • Infection
  • Malignancy
  • Under anticoagulant therapy
  • Hypersensitivity to iron sucrose or Epo
  • Preoperative autologous blood donation
  • Use of iron or Epo and blood transfusion within the previous 1 month

研究组 & 干预措施

group IE

Experimental

The group IE received iron sucrose and erythropoietin-β (Epo-β) during the operation

干预措施: iron sucrose, erythropoietin-β (Drug)

group C

Placebo Comparator

The group C received saline as same method.

干预措施: normal saline (Drug)

结局指标

主要结局

postoperative hemoglobin

时间窗: postoperative 1, 2, 3, 5 day and 2, 6 week

次要结局

  • serum iron, ferritin, total iron binding capacity (TIBC) and transferrin saturation (TSAT)(preoperation and postoperation)

研究者

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

Hyo-Seok Na

Dr.

Seoul National University Bundang Hospital

研究点 (1)

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