Evaluation of the Aurora Xi New Nomogram Software 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Fenwal, Inc.
- 入组人数
- 6,735
- 试验地点
- 4
- 主要终点
- Rate of Significant Hypotensive Adverse Events
研究概览
简要总结
A clinical trial to evaluate the safety and effectiveness of the Aurora Xi Plasmapheresis System with a new plasma collection volume nomogram.
详细描述
A controlled, prospective, randomized, multicenter, IDE clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the Aurora Xi Plasmapheresis System (test arm) as compared to the currently marketed Optimized Nomogram on the Aurora Xi Plasmapheresis System (control arm). The new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. The trial will be conducted at a minimum of 3 plasma collection centers. Subjects will be randomized into the test and control arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must meet current safety guidelines for plasma donation as set forth by the FDA as well as those in the standard operating procedures established by the participating institution.
- •Enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again.
排除标准
- •Subjects not able or unwilling to give consent to participate.
- •Subjects withdrawn by a qualified healthcare provider due to safety concerns.
- •Subjects who are employed by the clinical site or Sponsor.
结局指标
主要结局
Rate of Significant Hypotensive Adverse Events
时间窗: From venipuncture through 72 hours post-donation.
The primary objective of this study is to demonstrate that the overall rate of significant hypotensive adverse events (SHAEs, IQPP DAE Classification 1.2-1.6) in donors using the Aurora Xi New Nomogram algorithm is less than double the SHAE rate in donors using the Aurora Xi Optimized Nomogram algorithm.
次要结局
- Rate of Severe Hypotensive Adverse Events Relative to Donor Type(From Venipuncture through 72 Hours post-donation.)
- Rate of Severe Hypotensive Adverse Events Relative to Sex(From venipuncture through 72 hours post-donation.)
- Rate of Severe Hypotensive Adverse Events Relative to Age(From venipuncture through 72 hours post-donation.)
- Rate of Severe Hypotensive Adverse Events Relative to Weight(From venipuncture through 72 hours post-donation.)
- Rate of Hypotensive Severe/Injury Adverse Events (IQPP DAE Classification 1.5 or 1.6)(From venipuncture through 72 hours post-donation.)
- Time From Start of Plasmapheresis Procedure to the First SHAE(From venipuncture through end of the procedure.)