ACTRN12622001447741尚未招募4 期
A two-arm, parallel-group double-blind randomisation controlled trial assessing the effect of of intravenous iron versus placebo administration on haemoglobin concentration in anaemic patients undergoing Major cardiac, abdominal, or vascular surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 240
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
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Perioperative group and Recovery group
- •Patients who meet the following criteria at the start of treatment are eligible for the study:
- •1.Adults (greater than or equal to 18 years)
- •2.Undergoing planned or unplanned (elective/expedited or emergent) cardiac surgery (bypass or valve), abdominal surgery (open or laparoscopic) or vascular surgery (open or hybrid) of the lower limb
- •3. Anaemia (Hb <130g/L in males and <120g/L) in females
- •4.Willing and able to undergo follow-up visits
排除标准
- •Perioperative group and Recovery group
- •Patients who, at the start of treatment, meet any of the following criteria are not eligible for the study:
- •1.Blood transfusion at operation or blood transfusion in previous 3 months
- •2.Erythropoietin or intravenous iron in the previous 4 weeks
- •3.Known hypersensitivity to (ferric carboxymaltose or equivalent) or its excipients
- •4.Active infection on therapeutic antibiotics
- •5.Known chronic liver disease
- •6.Known other cause for anaemia (eg. untreated B12 or folate deficiency or myelodysplasia)
- •7.Known family history of haemochromatosis or Transferrin saturation (TSATS) >50%
- •8.Pregnancy or lactation
- •9.Unable to provide written informed consent
研究者
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