NCT02390102

Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Anemia
• Aortic Stenosis

Interventions

Type	Name	Description
DRUG	Erythropoietin	Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose
DRUG	Placebo	Saline solution 0.9%

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-06-01
• Completion: 2016-06-01
• First posted: 2015-03-17
• Last updated: 2018-07-17

Locations

1 site across 1 country: Canada