Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
研究概览
简要总结
Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Status post placement of durable ventricular assist device with stable clinical status for >30days
- •Hemoglobin >6 g/dL AND <13 g/dL (men) or <12 g/dL (women) within last 90 days
- •Serum ferritin <100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation <20% within last 90 days
- •Able and willing to provide written informed consent
排除标准
- •Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
- •History of anaphylaxis
- •Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months
- •Renal failure on hemodialysis
- •Respiratory failure on mechanical ventilation
- •Disabling Stroke
- •Ventricular assist device thrombosis
- •Evidence of active gastrointestinal bleeding or other active blood loss
- •Hospitalization <30 days
- •Pregnant or breastfeeding women
研究组 & 干预措施
Ferumoxytol injection treatment
干预措施: Ferumoxytol injection (Drug)
结局指标
主要结局
Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
时间窗: Month 6
次要结局
未报告次要终点