Prospective, Randomized, Controlled, Multicenter Clinical Trial to Demonstrate the Safety and Effectiveness of the NexSys® PCS Plasma Collection System With the Percent Plasma Nomogram (PPN) Feature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,443
- 试验地点
- 4
- 主要终点
- Rate of Significant Hypotensive Adverse Events
研究概览
简要总结
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
详细描述
Prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the United States. The objective of the trial is to study the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma collection system. Subjects will be randomized into an intervention and control arm. The control arm will donate plasma using the current software. The intervention arm will donate plasma using a novel software that supports a more individualized collection approach.
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 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Donors must be qualified to donate plasma per individual site's screening procedures which are in compliance with IQPP standards. If donors do not meet inclusion criteria at subsequent donations but have already been enrolled in the clinical trial, they are eligible to remain in the clinical trial and to donate plasma within the clinical trial once they meet eligibility criteria again, except if they fulfill any of the exclusion criteria listed below.
排除标准
- •All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.
- •Subject not able or willing to give consent to participate in the clinical trial.
- •Subject donated plasma outside of the present clinical trial after enrolling in this clinical trial.
- •Subjects are withdrawn from the clinical trial due to safety concerns by the qualified healthcare providers.
- •In addition, all donors for whom a BMI for use in the PPN feature cannot be reliably calculated will be excluded
结局指标
主要结局
Rate of Significant Hypotensive Adverse Events
时间窗: Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial.
The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome.
次要结局
- Rate of Significant Hypotensive Adverse Events Relative to Bodyweight(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Severe Hypotensive Adverse Events(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Volume(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Time From Start of Collection to First Significant Hypotensive Adverse Event(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to BMI(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Donor Status(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Rate of Significant Hypotensive Adverse Events Relative to Gender(Up to approximately 3 months, depending on time of enrollment into the trial.)
- Total Volume(Up to approximately 3 months, depending on time of enrollment into the trial.)