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

• ClinicalTrials.gov Identifier: NCT03607825
• Recruitment Status: Completed
• First Posted: July 31, 2018
• Last Update Posted: June 4, 2021
• Sponsor: Minnetronix
• Information provided by (Responsible Party): Minnetronix

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).

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

• 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

Arms and Interventions

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

Outcome Measures

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

• 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 > 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

Contacts and Locations

Locations

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

Minnetronix

More Information

• Responsible Party: Minnetronix
• ClinicalTrials.gov Identifier: NCT03607825
• Other Study ID Numbers: R1.0 11July18
• First Posted: July 31, 2018
• Last Update Posted: June 4, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

aneurysmal

Additional relevant MeSH terms:

Subarachnoid Hemorrhage; Hemorrhage; Pathologic Processes; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases