FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

Purpose

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).

Condition

  • Subarachnoid Hemorrhage

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Neurapheresis System
CSF filtration
  • Device: Neurapheresis System
    CSF filtration system and lumbar catheter

Recruiting Locations

Memorial Hermann
Houston, Texas 77001

More Details

Status
Recruiting
Sponsor
Minnetronix

Study Contact

Laura Verbick
651-917-4060
lverbick@minnetronixmedical.com

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.