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临床试验/EUCTR2019-003819-56-DK
EUCTR2019-003819-56-DK进行中(未招募)1 期

Effects of intravenous administered iron in non-anemic iron deficient patients with colorectal cancer. A double blinded clinical randomized trial.

Centre for Surgical Science0 个研究点目标入组 134 人开始时间: 2020年1月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
134

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria
  • -Planned for curative intended elective colon or rectum cancer surgery
  • -UICC stage I-III
  • -Age = 18
  • -Hgb > 7.0 for both men and women
  • -Serum ferritin =100 µg/L for both men and women
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 67
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 67

排除标准

  • -Chronic kidney failure, with need for dialysis
  • -Metachronous diagnosed cancer
  • -Unable to speak and understand Danish
  • -Cognitive impairment e.g. moderate to severe dementia
  • -Severe active infection
  • -Known allergy of monofer
  • -Contraindication for iv. iron infusion
  • -Withdrawal of informed consent
  • -Neoadjuvant chemo or radiation therapy
  • - Pregnant women

研究者

发起方
Centre for Surgical Science

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