Is intravenous iron and darbepoetin more effective than oral iron in reducing blood transfusion requirements for patients undergoing cardiac surgery - Preoperative treatment of a low haemoglobin in cardiac surgery

Brighton & Sussex University Hospitals NHS Trust0 个研究点目标入组 350 人开始时间: 2012年7月19日最近更新: 2012年9月18日

适应症

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•1. Preoperative haemoglobin 10.0-13.0g/dl 2. Serum ferritin <100 mcg/L or 100-800 mcg/L AND transferrin saturation <30% 3. Scheduled first time cardiac surgery - coronary artery bypass grafting and/or repair/replacement of cardiac valve/s or ascending aorta 4. Elective surgery i.e. not continuously an in-patient between study enrolment and surgery
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•1. Haemoglobin <10.0 or>13.0 g/dl 2. Patient intends to refuse allogeneic blood transfusion in the perioperative period 3. Patient is receiving renal replacement therapy - haemodialysis or peritoneal dialysis 4. Patient has history of allergic or toxic reaction to any of the study drugs (ferrous sulphate, darbepoetin or Monofer or Ferrinject) or other intravenous iron preparation 5. Patient has significant acute or chronic hepatic disease - defined clinically 6. Patient is undergoing chemotherapy for cancer 7. Redo cardiac surgery 8. Planned surgery requires hypothermic (<30 deg C)circulatory arrest 9. Pregnant 10. Age<18 years 11. Lacks mental capcity to consent 12. Already taking part in another study that could affect the primary endpoint (blood transfusion)

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