FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension (PILLAR-XT)

Minnetronix

Status: Completed

Conditions: Subarachnoid Hemorrhage

Treatments: Device: Neurapheresis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03607825

R1.0 11July18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 > 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Neurapheresis System

Experimental group

Description:

CSF filtration

Treatment:

Device: Neurapheresis System