Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:9/9/2018
Start Date:March 23, 2017
End Date:August 31, 2018

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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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
4
sites
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Fred Rincon, M.D.
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Andrew W Grande, MD
Phone: 612-624-8117
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Houston, Texas 77030
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Houston, TX
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