ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 7
- 主要终点
- Mean Change in Cisternal Blood From Enrollment to Catheter Removal
研究概览
简要总结
The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH).
详细描述
The PILLAR-XT study is designed to further confirm safety and characterize efficacy of Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and does not detract from the established care pathways, or deny enrolled subjects proven therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators who are already trained in the treatment and care of SAH patients and insertion/management of lumbar drains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Modified Fisher Grade 2, 3 or 4
- •Hunt & Hess I-IV
- •First aneurysmal SAH
- •Patient is ≤ 48 hours post bleeding event
- •World Federation of Neurosurgeons (WFNS) Grades I-IV
排除标准
- •Pregnancy
- •Patients with a SAH due to mycotic aneurysm or AV malformation
- •Patients who present with an acute MI or unstable angina
- •Imaging demonstrates supratentorial mass lesions > or = 15 cc
- •Imaging demonstrates > or = 2 mm of mid-line-shift associated with infarction and or edema
- •Effacement of the basilar cisterns
- •Vasospasm on admission as defined by angiographic evidence
- •Patients with a coagulopathy that cannot be reversed
- •Thrombocytopenia def. platelet count < 100,000
- •Patients on low molecular weight heparin such as Lovenox
- •Non-communicating Obstructive hydrocephalus
- •Existing hardware that prevents accurate CT imaging
- •Pre-existing Lumbar Drain
- •Local skin infections or eruptions over the puncture site
- •Signs of CNS systemic infection, sepsis or pneumonia
结局指标
主要结局
Mean Change in Cisternal Blood From Enrollment to Catheter Removal
时间窗: Enrollment to Catheter Removal (Immediately post treatment)
Mean Change in Cisternal Blood measured by the Hijdra Score as Documented by CT, represented as a percent change. The Hijdra Score evaluates 10 cisterns and fissures within the brain for the quantity of blood present on a 0-3 scale. 0 means no blood present, 1 is a small amount, 2 is moderately filled, and 3 is completely filled. The 10 scores are added up. A Hijdra Score of 0 means no blood present (normal) and a Hijdra Score of 30 means all the cisterns and fissures are completely filled with blood (poor outcome).
次要结局
- Mean Change in Red Blood Cells From Before to After the Treatment Period.(Catheter Insertion to Catheter Removal (Immediately post treatment))
- Mean Change in Total Protein From Before to After the Treatment Period(Catheter Insertion to Catheter Removal (Immediately post treatment))