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

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ClinicalTrials.gov Identifier: NCT03607825
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Minnetronix

Study Description
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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).

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Device: Neurapheresis System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
Actual Study Start Date : December 25, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neurapheresis System
CSF filtration
 Device: Neurapheresis System
CSF filtration system and lumbar catheter


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in Cisternal Blood [ Time Frame: Immediately post treatment ]
    Documented by CT


Secondary Outcome Measures :
  1. Mean Change in Red Blood Cells [ Time Frame: Immediately post treatment ]
    CSF analysis of RBCs

  2. Mean Change in Total Protein [ Time Frame: Immediately post treatment ]
    CSF analysis of Total Protein


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607825


Contacts
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Contact: Julie Messer 651-917-4060 jmesser@minnetronix.com

Locations
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United States, Texas
Memorial Hermann Recruiting
Houston, Texas, United States, 77001
Contact: Julie Messer         
Sponsors and Collaborators
Minnetronix
More Information
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Responsible Party: Minnetronix
ClinicalTrials.gov Identifier: NCT03607825     History of Changes
Other Study ID Numbers: R1.0 11July18
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Minnetronix:
aneurysmal
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases