FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

Not Applicable

Completed

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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 > 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

Arm && Interventions

Group	Intervention	Description
Neurapheresis System	Neurapheresis System	CSF filtration

Primary Outcome Measures

Name	Time	Method
Mean Change in Cisternal Blood From Enrollment to Catheter Removal	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).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Red Blood Cells From Before to After the Treatment Period.	Catheter Insertion to Catheter Removal (Immediately post treatment)	Mean Change in Red Blood Cells as measured by CSF analysis of RBCs, represented as a percent change. The RBCs are measured in the CSF in quantity of RBC (10\^6) per mm\^3. The change is calculated using the first available RBC measurement (at either Catheter Insertion or after 1 hour of CSF Filtration, if first measurement unavailable) compared to the last available RBC measurement before the catheter was removed.
Mean Change in Total Protein From Before to After the Treatment Period	Catheter Insertion to Catheter Removal (Immediately post treatment)	Mean Change in Total Protein as measured by CSF analysis of RBCs, represented as a percent change. The Total Protein is measured in the CSF in quantity of mg/dL. The change is calculated using the first available Total Protein measurement (at either Catheter Insertion or after 1 hour of CSF Filtration, if first measurement unavailable) compared to the last available Total Protein measurement before the catheter was removed.

Locations (4): Mount Sinai
🇺🇸
New York, New York, United States
University of Florida
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Gainesville, Florida, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Memorial Hermann
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Houston, Texas, United States