Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy and safety of evacuation of intraventricular hematoma by Active External Ventricular Drainage (IRRAflow) with tPA administration compared to Passive External Ventricular Drainage (EVD) with tPA administration.
研究概览
简要总结
Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.
详细描述
The ARCH study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with IRRAflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tPA. This might affect the patient neurological outcome assessed by GCS and mRankin scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 EVD
- •Active treatment
- •Signed informed consent obtained
- •a. Based on institutional and country laws
- •Spontaneous ICH with maximum 30 square cm's
- •If needed, normal coagulation profile (PT, PTT, platelet count)
- •Treatment within 72 hours of ictus
- •Ability to administer 2.0 mg of tPA per day for 3 days
排除标准
- •Age < 18 years
- •No need of EVD
- •Patient has fixed and dilated pupils
- •Coagulopathy uncorrectable
- •Vascular pathology (e.g. Aneurysm involvement, AVM involvement)
- •Pregnant women
研究组 & 干预措施
Treatment Arm #1
IRRAflow with manual tPA administration followed by Active Fluid Exchange
干预措施: IRRAflow (Device)
Treatment Arm #2
IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange
干预措施: IRRAflow (Device)
Treatment Arm #3
Standard EVD with manual tPA administration
干预措施: EVD (Device)
结局指标
主要结局
Efficacy and safety of evacuation of intraventricular hematoma by Active External Ventricular Drainage (IRRAflow) with tPA administration compared to Passive External Ventricular Drainage (EVD) with tPA administration.
时间窗: Intra-procedure
Efficacy is defined as the efficiency of each arm to remove the hematoma (70% cm3). Safety is measured as the frequency of bacterial central nervous system (measures as positive bacterial growth in cerebrospinal fluid), symptomatic brain bleeds (clinical symptoms drop in modified Rankin scale), and mortality (death).
Radiographic evaluation of ventricular blood removal as measured by head CT scan
时间窗: Intra-procedure
Change in blood volume (cm3) measured between stability scan and end of treatment scan.
Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale.
时间窗: 0-30 days post discharge from hospital
Defined as the comparison of patients outcomes between the three groups as measured by Glasgow Coma Scale, extended Glasgow Outcome Scale, and modified Rankin Scale.
次要结局
- Technical Success(Intra-Procedural)
- Procedural Success(Intra-Procedural)
- Safety - Catheter misplacement(Intra-Procedural)
- Safety - Infection(Intra-Procedural)
- Safety - Bleeding events(Intra-Procedural)