FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:2/14/2019
Start Date:December 25, 2018
End Date:December 2019
Contact:Julie Messer
Email:jmesser@minnetronix.com
Phone:651-917-4060

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ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension

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).

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 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

- 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
We found this trial at
1
site
Houston, Texas 77030
?
mi
from
Houston, TX
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