NCT02872636已完成不适用
Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Minnetronix8 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年3月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Device/System Safety - Adverse events related to the filtration procedure
研究概览
简要总结
The objective of this feasibility study is to demonstrate the safety and feasibility of using an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the same catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 or older
- •Informed consent by the patient or his/her legally authorized representative
- •Modified Fisher Grade 2, 3, or 4
- •Hunt & Hess I-III
- •First aneurysmal SAH that has been confirmed by Angio, CTA or MRA
- •Patient is ≤ 48 hours post bleeding event
- •World Federation of Neurosurgeons (WFNS) Grades I-IV and those Grade V patients who improve to Grade IV or less after ventriculostomy.
排除标准
- •Patients with a SAH due to mycotic aneurysm or AV malformation
- •Patients who present with an acute MI or unstable angina
- •Patients with uncontrolled diabetes
- •Patients who present with a creatinine > 2.0mg/dl
- •Imaging demonstrates supratentorial mass lesions greater than 50 cc
- •Imaging demonstrates more than 5 mm of mid-line-shift associated with infarction and or edema
- •Effacement of the basilar cisterns (suprasellar, ambient, chiasmatic and quadrageminal)
- •Vasospasm on admission as defined by angiographic evidence
- •Patients with a coagulopathy that cannot be reversed per the professional discretion of the investigator
- •Thrombocytopenia def. platelet count < 100,000
- •Patients on low molecular weight heparin e.g., Lovenox
- •Patients on Clopidogrel bisulfate (Plavix) or other chronic platelet inhibitors
- •Patients with a documented history of cirrhosis
- •Patients who will be managed with supportive care rather than intervention
- •Obstructive hydrocephalus i.e., non-communicating
- •Pregnancy
- •History of posterior fusion hardware that would interfere with placement of the catheter
- •Pre-existing Lumbar Drain
- •Local skin infections or eruptions over the puncture site
- •Signs of systemic infection/sepsis or pneumonia
- •Lumbar puncture within 6 hours
- •Concurrent participation in another study which is not observational or retrospective in nature without prior approval from the Sponsor
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Spinal catheter insertion with extracorporeal filtration of CSF (Device)
结局指标
主要结局
Device/System Safety - Adverse events related to the filtration procedure
时间窗: 30 days
Adverse events related to the filtration procedure
Adverse events related to the system catheter insertion
时间窗: 30 days
Nerve or tissue damage related to catheter insertion
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
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