Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Treatments: Epoetin Alfa

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