Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
研究概览
简要总结
Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.
详细描述
This is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the Spectra Optia system. Data collection will include procedures in 2- 3 different centers in Europe done between November 2011 and April 2014.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having received a minimum of one platelet depletion procedure via the Spectra Optia system.
- •Availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the Spectra Optia system.
排除标准
- 未提供
结局指标
主要结局
Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure
时间窗: on average this will be within 15 minutes after the end of the procedure
(PLTpre - PLTpost) / PLTpre x 100%
Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.
时间窗: on average this will be within 15 minutes after the end of the procedure
(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)
Adverse Events
时间窗: during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).
次要结局
未报告次要终点