ChiCTR2300071951招募中Unknown
Please fill in the data management platform. Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients
Internal funding of the department1 个研究点 分布在 1 个国家开始时间: 2018年7月2日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 试验地点
- 1
- 主要终点
- Prevalence of anaemia and iron deficiency
研究概览
简要总结
The objectives of this study are to:
- Determine the preoperative and postoperative prevalences of anaemia and iron deficiency
- Assess the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on postoperative outcomes up to 30 days after surgery.
- Evaluate the impact of single dose intravenous iron isomaltoside (20mg/kg for body weight<50kg, 1000 mg for body weight>50kg), given 3-10 weeks before elective cardiac surgery, on exercise tolerance and performance up to 30 days after surgery
- Determine the safety profile of intravenous iron isomaltoside and its effect on preoperative and postoperative haemoglobin and ferritin concentrations.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •The inclusion criteria will be adults scheduled for elective cardiac surgery within 3-10 weeks with written informed consent, irrespective of their haemoglobin and iron status. We will recruit 460 consecutive patients undergoing major elective coronary artery bypass graft and/or valve surgery of anticipated duration of more than three hours.
排除标准
- •We will exclude patients undergoing aortic dissection repair due to the intrinsic high risk of bleeding with this type of operation; emergency cardiac surgery; family or personal history of haemochromatosis; known reasons for anaemia, such as vitamin B12 or folate deficiency, haemoglobinopathy, thalassemia, chronic renal failure; previous intravenous iron therapy or blood transfusion in last 12 weeks; known hypersensitivity to intravenous iron therapy; body temperature more than 37.5°C or receiving non-prophylactic antibiotics; chronic liver disease and/or alanine aminotransferase or aspartate aminotransferase concentration above three times the upper limit of normal; history of asthma, allergic eczema or other atopic allergy; and rheumatoid arthritis with symptoms or signs of active inflammation.
研究组 & 干预措施
Single dose intravenous iron isomaltoside group
No intravenous iron therapy group
结局指标
主要结局
Prevalence of anaemia and iron deficiency
Exercise performance
Days (alive and) at home within 30 days of surgery
次要结局
- Units of perioperative allogenic blood transfused
- Chinese Veterans Specific Activity Questionnaire
- Cardiac Postoperative Morbidity Survey
- Quality of Recovery-15 item
- World Health Organization Disability Assessment Schedule 2.0
研究者
研究点 (1)
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