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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Rate of red blood cell transfusion
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •Active cancer or very high risk of thromboembolic events
- •Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
- •No written consent
研究组 & 干预措施
Erythropoietin
Dose: darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose Administered at days 10 (±4) and 1 (±1) before the index procedure.
干预措施: Erythropoietin (Drug)
Placebo
Dosage: Saline solution 0.9% Administered at days 10 (±4) and 1 (±1) before the index procedure.
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of red blood cell transfusion
时间窗: 30 days
次要结局
- Number of packets of red cells(30 days)
- Hemoglobin value(For the duration of hospital stay, an expected average of 1 week)
- Peak of troponin and creatinine kinase(For the duration of hospital stay, an expected average of 1 week)
- Incidence of acute kidney injury(At 48 hours following procedure)
- Need of hemodialysis(For the duration of hospital stay, an expected average of 1 week)
- Rate of new onset atrial fibrillation(For the duration of hospital stay, an expected average of 1 week)
- Days of hospital stay(For the duration of hospital stay, an expected average of 1 week)
- Days of intensive unit care stay(For the duration of hospital stay, an expected average of 1 week)
- Mortality(At 30-day, 1-year)
- Quality of life(At 30-day, 6-month, 1-year)
- Cost-effectiveness analysis of Erythropoietin-therapy(For the duration of hospital stay, an expected average of 1 week)
- Stroke rate(At 30-day)
研究者
Josep Rodes-Cabau
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec