Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement
- Registration Number
- NCT02390102
- Lead Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
-
Patients ≥60-year old
-
Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
-
Anemia defined according to the World Health Organization (WHO) definition 69:
- Men: Hemoglobin<130 g/L
- Women: <120 g/L
- Contraindication for transcatheter aortic valve replacement.
- Erythropoietin treatment within last 30 days before Aortic Valve Replacement
- Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
- Ferritin>800 µg/L
- Uncontrolled hypertension (Blood pressure>175/95 )
- Platelet count>450,000/L
- Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
- Dialysis patients
- 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
- Active cancer or very high risk of thromboembolic events
- Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
- No written consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Dosage: Saline solution 0.9% Administered at days 10 (±4) and 1 (±1) before the index procedure. Erythropoietin Erythropoietin Dose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.
- Primary Outcome Measures
Name Time Method Rate of red blood cell transfusion 30 days
- Secondary Outcome Measures
Name Time Method Number of packets of red cells 30 days Hemoglobin value For the duration of hospital stay, an expected average of 1 week 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 Days of hospital stay For the duration of hospital stay, an expected average of 1 week 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
Trial Locations
- Locations (1)
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Quebec, Canada