Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for White Blood Cell Depletion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
研究概览
简要总结
This study is a multicenter, retrospective data collection of routine clinical use with the Spectra Optia® apheresis system for white blood cell depletion.
详细描述
The goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the Spectra Optia® apheresis system.
In order to do so, retrospective data on white blood cell depletion procedures with the Spectra Optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.
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 1 white blood cell depletion procedure via the Spectra Optia Apheresis System
排除标准
- 未提供
结局指标
主要结局
Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure
时间窗: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%
Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.
时间窗: immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure
Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)
Adverse Events
时间窗: Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.
Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.
次要结局
未报告次要终点