Brief Title
Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement
Official Title
Combined ErythroPoietin and Iron Therapy for AnemiC Patients With Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve REplacement- The EPICURE Trial A Prospective Double Blind Randomized Trial
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).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Rate of red blood cell transfusion
Secondary Outcome
Number of packets of red cells
Condition
Anemia
Intervention
Erythropoietin
Study Arms / Comparison Groups
Erythropoietin
Description: Dose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
117
Start Date
June 2012
Completion Date
June 2016
Primary Completion Date
June 2015
Eligibility Criteria
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
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Josep Rodes Cabau, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02390102
Organization ID
EPICURE
Secondary IDs
CER-20809
Responsible Party
Principal Investigator
Study Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study Sponsor
Josep Rodes Cabau, MD, Principal Investigator, Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Verification Date
July 2018