ChiCTR2300071951
正在进行
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2023-05-30
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Cardiovascular disease
Please fill in the data management platform. Impact of intravenous iron therapy on outcomes and exercise performance in cardiac surgical patients
Impact of treating iron deficiency with intravenous iron therapy during prehabilitation period on outcomes and exercise performance in cardiac surgical patients
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.
队列研究
其它
N/A
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Internal funding of the department
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230
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2018-07-02
2024-05-31
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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.；
登录查看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.；
登录查看Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong
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