【ChiCTR2300071951】Please fill in the data management platform. Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients

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基本信息

登记号

ChiCTR2300071951

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2023-05-30

临床申请受理号

靶点

适应症

Cardiovascular disease

试验通俗题目

Please fill in the data management platform. Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients

试验专业题目

Impact of treating iron deficiency with intravenous iron therapy during prehabilitation period on outcomes and exercise performance in cardiac surgical patients

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申请人名称

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联系人邮编

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临床试验信息

试验目的

The objectives of this study are to: 1. Determine the preoperative and postoperative prevalences of anaemia and iron deficiency 2. 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. 3. 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 4. Determine the safety profile of intravenous iron isomaltoside and its effect on preoperative and postoperative haemoglobin and ferritin concentrations.

试验分类

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试验类型

队列研究

试验分期

其它

随机化

N/A

盲法

试验项目经费来源

Internal funding of the department

试验范围

目标入组人数

230

实际入组人数

第一例入组时间

2018-07-02

试验终止时间

2024-05-31

是否属于一致性

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.；

研究者信息

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试验机构

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

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研究负责人邮编

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