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临床试验/ACTRN12620000314921
ACTRN12620000314921尚未招募4 期

Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery

The University of Western Australia0 个研究点目标入组 50 人开始时间: 2020年3月6日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Non-anaemic adults (haemoglobin >130g/L for males and 120g/L for females) 18 years of age or older with ferritin levels < 100 mcg/L
  • 2.Planned elective major surgical procedure with anticipated blood loss greater than 500 ml (as listed in Fiona Stanley Hospital Pre-operative Blood Management algorithm).

排除标准

  • 1.Anaemia (defined as per WHO criteria including haemoglobin <130g/L for males and 120g/L for females)
  • 2.Pre-operative evidence of bone marrow insufficiency (i.e. pre-operative haemoglobin <100 g/L, neutrophil count <1.8 x109/L, platelets <100 x109/L) or known haemoglobinopathy
  • 3.Diagnosed iron overload state (e.g. hereditary haemochromatosis)
  • 4.Patients unable/unwilling to receive blood products
  • 5.Pregnancy or lactation
  • 6.Patients administered parenteral iron or erythropoietin within six weeks prior to surgery or with known allergy/hypersensitivity to Ferric carboxymaltose (Ferinject®)
  • 7.Chronic renal disease requiring dialysis
  • 8.Chronic liver disease or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal range
  • 9.Patients unable to complete 6MWT
  • 10.Patients unwilling/unable to give consent

研究者

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