The objective of the study is to evaluate the efficacy of Erythropoietin (EPO) (+ iron) in reducing the rate of red blood cell transfusion requirements in patients with aortic stenosis undergoing transcatheter aortic valve replacement.
STUDY DESIGN Prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. The patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec. SAMPLE SIZE 100 patients (50 patients per group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
117
Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose
Saline solution 0.9%
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Canada
Rate of red blood cell transfusion
Time frame: 30 days
Number of packets of red cells
Time frame: 30 days
Hemoglobin value
Analysis g/L
Time frame: One day before index procedure
Hemoglobin value
Time frame: For the duration of hospital stay, an expected average of 1 week
Peak of troponin and creatinine kinase
Time frame: For the duration of hospital stay, an expected average of 1 week
Incidence of acute kidney injury
Acute kidney injury defined as \>25% decrease of estimated glomerular filtration rate (eGFR)
Time frame: At 48 hours following procedure
Need of hemodialysis
Time frame: For the duration of hospital stay, an expected average of 1 week
Rate of new onset atrial fibrillation
Time frame: For the duration of hospital stay, an expected average of 1 week
Days of hospital stay
Time frame: For the duration of hospital stay, an expected average of 1 week
Days of intensive unit care stay
Time frame: For the duration of hospital stay, an expected average of 1 week
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Mortality
Time frame: At 30-day, 1-year
Quality of life
Questionnaire, Visual scale
Time frame: At 30-day, 6-month, 1-year
Cost-effectiveness analysis of Erythropoietin-therapy
Time frame: For the duration of hospital stay, an expected average of 1 week
Stroke rate
Time frame: At 30-day