The Impact of Treatment of Anaemia With Intravenous Iron on Haematological Values for Patients After Colorectal Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in haemoglobin level
研究概览
简要总结
This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery.
The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.
详细描述
The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on haematological parameters for patients after elective colorectal surgery.
Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of haemoglobin, ferritin, red cell count and is superior compared to placebo.
Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood transfusions, postoperative complications and hospital stay.
The Objectives:
- To estimate the rate of preoperative anaemia in patients of elective colorectal surgery.
- To assess the dynamic changes of total blood count values in colorectal surgery patients treated with postoperative intravenous iron.
- To compare the changes in total blood count values over time in colorectal surgery patients treated with intravenous iron versus colorectal surgery patients of the control group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective colorectal cancer surgery
- •preoperative haemoglobin 90-120 g/l
- •preoperative plasma ferritin <100 mkg/l
排除标准
- •laparoscopic colorectal surgery
- •body mass <50kg
- •history of overdosage of iron products
- •family history of haemochromatosis, thalassaemia,
- •non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies)
- •under treatment with erythropoietin, intravenous iron or blood transfusion in the last 12 weeks
- •allergy to iron carboxymaltose or its supplements
- •body temperature > 37.5 °C or under antibiotic use
- •chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times over normal upper limit
- •patients ill with grave bronchial asthma
- •patients with manifestation of allergy
研究组 & 干预措施
Treatment
1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
干预措施: Iron isomaltoside (Drug)
Control
The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l).
干预措施: Saline (Drug)
结局指标
主要结局
Changes in haemoglobin level
时间窗: 4 weeks after surgery
Haemoglobin level will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
次要结局
- Changes of reticulocyte haemoglobin count(4 weeks after surgery)
- Number of participants with perioperative complications(4 weeks after surgery)
- Changes of mean corpuscular volume(4 weeks after surgery)
- Amount of intravenous fluid therapy(From date of randomization until the day of discharge, up to 2 weeks after surgery)
- Changes of reticulocyte count(4 weeks after surgery)
- Changes of plasma ferritin(4 weeks after surgery)
- Changes of mean corpuscular haemoglobin concentration(4 weeks after surgery)
- Rate of blood transfusion(From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery)
- Changes of red blood cell count(4 weeks after surgery)
- Duration of hospital stay(From the date of randomization until the day of discharge, up to 2 weeks after surgery)