ACTRN12616001219471招募中4 期
An iron infusion with Ferric Carboxymaltose as a technique of improving physiological reserve in iron deficient patients undergoing surgery for colorectal cancer: a randomized control trial
Peter MacCallum Cancer Centre0 个研究点目标入组 36 人开始时间: 2016年9月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- •1. Patients 18 years of age and older
- •2. Patients with histologically confirmed colorectal cancer presenting to Peter MacCallum Cancer Centre, or Epworth Hospital (Richmond and Eastern campuses).
- •3. Ferritin <100mcg/l or 100-300mcg/L and TSAT<20%
- •4. Normal Serum Vitamin B12 and Folate levels
- •5. Normal red cell folate and B12 levels
- •6. Patients planned for surgery colorectal surgery
排除标准
- •1. Hb (>130mg/dL male, or >120mg/dL female) & (either one of: Ferritin >300mcg/l, or Ferritin >100mcg/l and TSAT >20%)
- •2. Marked Iron deficiency anaemia precluding randomization: Hb < 110 mg/dL & Ferritin <20 mcg/l
- •3. Iron therapy contraindicated
- •4. Treatment with iron therapy or blood transfusion in the previous 12 weeks
- •5. Presentation for neoadjuvant CRT or Surgery within the study period
- •6. Patients with a known haematological abnormality (such as haemochromatosis or thalassemia, TSAT >50%)
- •7. Liver disease where ALT is above 3 times the upper limit of the normal range
- •8. Patients with a history of acquired iron overload or iron storage disorders
- •9. Previous hypersensitivity or allergic reactions to parentral (polymaltose/carboxymaltose) iron preparations
- •10. Patients unable to give informed consent
- •11. Physical disability preventing CPX, or contraindication in local CPX policy (such as angina at rest)
- •12. Patients included in other clinical trials that involve the administration of iron therapy
- •13. Blood transfusion in previous three months
研究者
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