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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03607825
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : June 4, 2021
Information provided by (Responsible Party):

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
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
Actual Primary Completion Date : January 11, 2021
Actual Study Completion Date : February 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT03607825

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Mount Sinai
New York, New York, United States, 10029
United States, Texas
Memorial Hermann
Houston, Texas, United States, 77001
Sponsors and Collaborators
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Responsible Party: Minnetronix Identifier: NCT03607825    
Other Study ID Numbers: R1.0 11July18
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
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
Keywords provided by Minnetronix:
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases