NCT01441375已完成不适用
Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 2
- 主要终点
- Sickle cell complications
研究概览
简要总结
This study is a retrospective chart review of sickle cell patients and will include patients whom have received blood transfusions and those whom have not. Of the transfused patients, it will also include those whom have received chelation therapy and those whom have not.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Sickle Cell Disease (SCD) and a confirmed genotype
- •Patients ≥ 16 years of age
- •Patients with ≥ 6 months of follow-up data available from first SCD treatment at the center after they reach 16 years old
- •At least one SF reading during a non-acute phase on or after the first SCD treatment at the center after they reach 16 years old
排除标准
- •Patients who participated in a clinical trial for an iron chelating medication or in a clinical trial for transfusions for SCD (1) within the six months before the index date or (2) during the patient observation period
- •Patients with sickle cell trait
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Sickle cell complications
时间窗: average of 5 years
次要结局
- Utilization of blood transfusions (patients with frequent transfusions only)(average of 5 years)
- Burden of iron overload (patients with frequent transfusions only)(average of 5 years)
- Overall survival(average of 5 years)
- Utilization of health care delivery to treat sickle cell complications(average of 5 years)
- Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only)(average of 5 years)
研究者
研究点 (2)
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