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临床试验/EUCTR2020-001389-12-DK
EUCTR2020-001389-12-DK进行中(未招募)1 期

The Postoperative Iron in Cardiac Surgery (PICS-) trial:A randomised clinical trial comparing the efficacy of single-, high-dose intravenous iron and oral iron for the treatment of anaemia following cardiac surgery. - PICS-trial

Aarhus University Hospital0 个研究点目标入组 110 人开始时间: 2020年9月3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
110

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

  • 1. Patients undergoing first-time, non-emergent cardiac surgery
  • 2. Moderate anemia on the first postoperative day (i.e. a haemoglobin concentration of = 5.0 mmol/l [8 g/dl] and < 6.8 mmol/l [11 g/dl])
  • 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 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • Absolute and relative contraindications to treatment with intravenous iron
  • Treatment with intravenous iron within 4 weeks prior to surgery.
  • Untreated vitamin B12 or folate deficiency.
  • Anticipated inability to perform a six-minute walk test.
  • Women of childbearing potential, pregnant and nursing women.
  • Anticipated postoperative length of stay in the intensive care unit (ICU) > 48 hours.
  • Patients incapable of giving consent personally.
  • Significantly increased risk of non-adherence or loss to follow-up.
  • Active participation in another interventional trial with potential impact on postoperative anaemia or exercise capacity.

研究者

发起方
Aarhus University Hospital

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