Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Residual blood volume by post bleed day 5
研究概览
简要总结
The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.
详细描述
The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - [Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)], intracranial abscess, and ventriculitis.
The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Residual blood volume by post bleed day 5
时间窗: Post-procedure day 5
The residual blood volume at day 5 will be calculated to determine the efficacy of the IRRAflow system compared to other external ventricular drains (EVDs)
Utility weighted modified Rankin Score
时间窗: End of study, at 6 months
Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. Scores range from 0 to 6, with 0 indicating no disability and 6 indicating death
次要结局
- Rate of blood clearance(Immediately before and after the procedure)
- Direct hospitalization costs(Discharge, up to 7 days post procedure)
- NSICU Length of Stay(Discharge, up to 7 days post procedure)
- Hospital Length of Stay (LOS)(Discharge, up to 7 days post procedure)
- Proportion of participants needing a shunt(Discharge, up to 7 days post procedure)
研究者
Christopher P Kellner
Associate Professor, Neurosurgery
Icahn School of Medicine at Mount Sinai