Anemia, Aortic Stenosis
Conditions
Keywords
Anemia, Severe aortic stenosis, Red blood cell transfusion, Erythropoietin
Brief summary
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.
Detailed description
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).
Interventions
DRUGErythropoietin
Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose
DRUGPlacebo
Saline solution 0.9%
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥60-year old 2. Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention 3. Anemia defined according to the World Health Organization (WHO) definition 69: 1. Men: Hemoglobin\<130 g/L 2. Women: \<120 g/L
Exclusion criteria
1. Contraindication for transcatheter aortic valve replacement. 2. Erythropoietin treatment within last 30 days before Aortic Valve Replacement 3. Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement 4. Ferritin\>800 µg/L 5. Uncontrolled hypertension (Blood pressure\>175/95 ) 6. Platelet count\>450,000/L 7. Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days) 8. Dialysis patients 9. Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure 10. Active cancer or very high risk of thromboembolic events 11. Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy 12. No written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of red blood cell transfusion | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin value | One day before index procedure | Analysis g/L |
| Peak of troponin and creatinine kinase | For the duration of hospital stay, an expected average of 1 week | — |
| Incidence of acute kidney injury | At 48 hours following procedure | Acute kidney injury defined as \>25% decrease of estimated glomerular filtration rate (eGFR) |
| Need of hemodialysis | For the duration of hospital stay, an expected average of 1 week | — |
| Rate of new onset atrial fibrillation | For the duration of hospital stay, an expected average of 1 week | — |
| Number of packets of red cells | 30 days | — |
| Days of intensive unit care stay | For the duration of hospital stay, an expected average of 1 week | — |
| Mortality | At 30-day, 1-year | — |
| Quality of life | At 30-day, 6-month, 1-year | Questionnaire, Visual scale |
| Cost-effectiveness analysis of Erythropoietin-therapy | For the duration of hospital stay, an expected average of 1 week | — |
| Stroke rate | At 30-day | — |
| Days of hospital stay | For the duration of hospital stay, an expected average of 1 week | — |
Countries
Canada
Outcome results
None listed