Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
研究概览
简要总结
The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).
Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years of age
- •Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- •Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- •Signed informed consent obtained by subject or Legally Authorized Representative
排除标准
- •Subject has fixed and dilated pupils
- •Pregnant women
- •Presence of Moyamoya
- •History or presence of clotting disorder.
- •Platelet count less than 100,000, INR greater than 1.4
结局指标
主要结局
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
时间窗: Immediately post-procedure
次要结局
- Indwell time of EVD/Drainage and IRRAflow Catheter(Immediately post-procedure)
- Length of ICU stay(Baseline)
- Rate of shunt dependency(Immediately post-procedure)
- Time to clearance of blood or bacterial mass as measured by head CT scan(Immediately post-procedure)
- Mortality rates - intraprocedural and at 30 days(30 days post subject discharge)
- Rate of catheter-related infection(Immediately post-procedure)
- Functional Status - at inclusion and 30 days(30 days post subject discharge)
研究者
Patrick Youssef
Clinical Assistant Professor of Neurological Surgery
Ohio State University