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

• ClinicalTrials.gov Identifier: NCT03607825
• Recruitment Status: Completed
• First Posted: July 31, 2018
• Results First Posted: October 6, 2022
• Last Update Posted: October 6, 2022
• 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 From Enrollment to Catheter Removal [ Time Frame: Enrollment to Catheter Removal (Immediately post treatment) ]
   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 :

1. Mean Change in Red Blood Cells From Before to After the Treatment Period. [ Time Frame: Catheter Insertion to Catheter Removal (Immediately post treatment) ]
   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.
2. Mean Change in Total Protein From Before to After the Treatment Period [ Time Frame: Catheter Insertion to Catheter Removal (Immediately post treatment) ]
   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.

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

  Study Documents (Full-Text)

Documents provided by Minnetronix:

Study Protocol and Statistical Analysis Plan  [PDF] March 11, 2020

More Information

• Responsible Party: Minnetronix
• ClinicalTrials.gov Identifier: NCT03607825
• Other Study ID Numbers: R1.0 11July18
• First Posted: July 31, 2018
• Results First Posted: October 6, 2022
• Last Update Posted: October 6, 2022
• 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