Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Flow Rate
研究概览
简要总结
Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis.
Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port.
Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18 years of age.
- •Referred for change from a vortex port to a powerflow port.
- •Previously placed or scheduled placement of one of two configurations of the PowerFlow port
排除标准
- •Unable to read and understand English.
- •Unable to provide informed consent.
结局指标
主要结局
Change in Flow Rate
时间窗: 1 year following new port configuration placement
The study will compare mean change flow rate for pheresis sessions with the old system versus pheresis sessions with one of two new configurations by averaging the flow rate for up to 5 sessions using the new port configuration.
Change in Procedure Time
时间窗: 1 year following new port configuration placement
The study will compare mean change in procedure time for pheresis sessions with the old system versus pheresis sessions with one of two new configurations.
次要结局
- Change in Use of Tissue Plasminogen Activator(1 year following new port configuration placement)