Efficacy of Preoperative Intravenous Iron Isomaltoside in Colorectal Cancer Surgical Patients With Iron Deficiency Anaemia Compared to Standard Care: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Preoperative change in serum ferritin (mcg/L)
研究概览
简要总结
Iron deficiency anaemia is a common condition among colorectal surgical patient. Untreated anaemia would lead to increase in blood transfusion, surgical complications and mortality. Treatment with oral iron sulphate is poorly tolerated due to side effects. Intravenous iron supplement provides an alternative way to rapidly replace iron deficit during the preoperative period among surgical patients. Evidence is growing for its effect in rising hemoglobin level and reducing blood transfusion, at the same time supporting its safety profile.
The investigators plan for a single-centered, randomized controlled trial to examine the effect of intravenous iron compared to standard care in terms of hemoglobin level/serum ferritin increment, need for blood transfusion, duration of hospital stay, quality of recovery and surgical complication rate, as well as safety profile among colorectal cancer surgical patients in Hong Kong. The investigator propose the following pilot RCT for exploring the effect size and study process in conducting the above-mentioned large-scale RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old with written informed consent
- •Anaemia defined as: hemoglobin concentration < 13g/dL (same cut-off for both male and female patients according to the International consensus statement on the perioperative management of anaemia and iron deficiency)2
- •Laboratory test confirmed iron deficiency: serum ferritin <30mcg/L alone or serum ferritin 30-100mcg/L with TSAT < 20%
排除标准
- •Pregnancy or lactation
- •Other known causes of anaemia apart from iron deficiency: untreated B12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis
- •Presence of iron overload (serum ferritin > 300g/dL or TSAT > 50%); known hemochromatosis
- •Previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment
- •Known hypersensitivity towards iron isomaltoside
- •Significant liver function derangement (AST/ALP exceeding three times upper limit of normal range)
- •Participation in another ongoing interventional clinical trial(s)
- •Patients with less than 3 weeks waiting time to surgery
研究组 & 干预措施
Treatment arm
intravenous iron isomaltose 3-10 weeks before operation date. The dose will be determined by the patient's body weight: > 50kg: 1000mg; <50kg: 20mg/kg body weight, to be infused over 30 minutes. 2 weeks after intravenous iron isomaltoside administration, blood test for hemoglobin level and iron profile would be repeated. Subjects with hemoglobin level less than 10g/dL will receive a second dose of intravenous iron isomaltoside. The second dose would be identical to the first dose
干预措施: iron isomaltoside(Monofer®) (Drug)
结局指标
主要结局
Preoperative change in serum ferritin (mcg/L)
时间窗: 3 weeks to 10 weeks
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Preoperative change in hemoglobin concentration (g/dL)
时间窗: 3 weeks to 10 weeks
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
次要结局
- Days (alive and) at home within 30 days of surgery (DAH30)(up to post op day 30)
- Duration of hospital stay (days)(1 days up to 1 month)
- Units of red blood cells transfused in perioperative period(3 weeks to 12 weeks)
- Quality of recovery as measured by questionnaire (QoR-15(Chinese))(post op day 3)
- Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions(up to post op day 30)
- Rate of surgical complications(up to post op day 30)
研究者
Dr. Pui Lam Polly FUNG
Resident trainee
Prince of Wales Hospital, Shatin, Hong Kong