HL-CA-1600, Hemolung RAS Registry. A Retrospective Registry Involving Voluntary Reporting of De-identified, Standard of Care Data Following the Commercial Use of the Hemolung Respiratory Assist System (RAS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 99
- 主要终点
- Incidents
研究概览
简要总结
The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified, standard of care data following the commercial use of the Hemolung RAS.
详细描述
ALung's post-market Hemolung RAS Registry Program provides a continuum for measuring the Hemolung RAS effectiveness and safety in a real-world setting beyond the results reported in pre-market clinical feasibility studies. The Hemolung RAS Registry Program is part of ALung's 1) evaluation of clinical evidence throughout the life cycle of the product, 2) longer term residual risk assessment of the product, and 3) commitment to maintain quality systems and integrate continuous quality improvements in the product.
On a voluntary basis, participating physicians and institutional staff enter de-identified data online in the secure, password protected, regulatory-compliant Hemolung RAS Registry Portal in a retrospective manner following a patient's ICU discharge, status at 28 days post-Hemolung therapy, or death whichever is earlier. There is no requirement to collect and report data outside of standard of care. The program's methodology, data monitoring and statistical analysis plan is consistent with this type of initiative in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidents
时间窗: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Outcome at 28 days
时间窗: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days in the ICU
时间窗: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days on Hemolung therapy
时间窗: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
次要结局
- Hemolung-assisted weaning(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)
- Patient mobility on Hemolung(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)
- Blood product usage and hematologic effects on Hemolung(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)
- Arterial blood gas changes on Hemolung(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)
- Ventilatory mode and setting changes on Hemolung(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)
- CO2 removal and blood flow performance(Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.)