CompletedPhase 3

Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

Canada117 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Rate of red blood cell transfusion

Timeframe: 30 days

Trial details

NCT IDNCT02390102

SponsorCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

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