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临床试验/NCT04880499
NCT04880499已完成不适用

Emacrit Plus in Prosthetic Hip and Knee Surgery

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月21日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Change of blood hemoglobin levels
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Randomized controlled trial to evaluate the efficacy of oral iron supplementation plus cofactors in reducing the prevalence of preoperative anemia in a cohort of 60 patients undergoing elective prosthetic hip or knee surgery.

研究设计

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

入排标准

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

入选标准

  • •Males and females
  • •ASA 1, 2, or 3
  • •No neuropsychiatric conditions
  • •Acceptance of informed consent
  • •Elective prosthetic hip or knee surgery

排除标准

  • •Present or past neuropsychiatric conditions
  • •Hip or knee revision surgery
  • •Use of iron as dietary supplement
  • •Known erythrocytosis
  • •Incompatible hypersensitivities
  • •Iron metabolism disorders
  • •Lymphoproliferative disorders

结局指标

主要结局

Change of blood hemoglobin levels

时间窗: Baseline and 60 days +/- 15 days

Change of hemoglobin concentration (g/dl) from baseline and after 60 days +/- 15 days

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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