Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

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

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