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

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurapheresis System
Sponsored by
Minnetronix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring aneurysmal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Florida
  • University of Minnesota
  • Mount Sinai
  • Memorial Hermann

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neurapheresis System

Arm Description

CSF filtration

Outcomes

Primary Outcome Measures

Mean Change in Cisternal Blood From Enrollment to Catheter Removal
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

Mean Change in Red Blood Cells From Before to After the Treatment Period.
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
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.

Full Information

First Posted
July 23, 2018
Last Updated
September 30, 2022
Sponsor
Minnetronix
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1. Study Identification

Unique Protocol Identification Number
NCT03607825
Brief Title
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
Acronym
PILLAR-XT
Official Title
ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 25, 2018 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
February 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnetronix

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
aneurysmal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurapheresis System
Arm Type
Experimental
Arm Description
CSF filtration
Intervention Type
Device
Intervention Name(s)
Neurapheresis System
Intervention Description
CSF filtration system and lumbar catheter
Primary Outcome Measure Information:
Title
Mean Change in Cisternal Blood From Enrollment to Catheter Removal
Description
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).
Time Frame
Enrollment to Catheter Removal (Immediately post treatment)
Secondary Outcome Measure Information:
Title
Mean Change in Red Blood Cells From Before to After the Treatment Period.
Description
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.
Time Frame
Catheter Insertion to Catheter Removal (Immediately post treatment)
Title
Mean Change in Total Protein From Before to After the Treatment Period
Description
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.
Time Frame
Catheter Insertion to Catheter Removal (Immediately post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 > 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
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

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