Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter (PILLAR)

The objective of this feasibility study is to demonstrate the safety and feasibility of using an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the same catheter.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage
• Intervention / Treatment: Device: Spinal catheter insertion with extracorporeal filtration of CSF

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18 years or older
• Informed consent by the patient or his/her legally authorized representative
• Modified Fisher Grade 2, 3, or 4
• Hunt & Hess I-III
• First aneurysmal SAH that has been confirmed by Angio, CTA or MRA
• Patient is ≤ 48 hours post bleeding event
• World Federation of Neurosurgeons (WFNS) Grades I-IV and those Grade V patients who improve to Grade IV or less after ventriculostomy.

Exclusion Criteria:

• Patients with a SAH due to mycotic aneurysm or AV malformation
• Patients who present with an acute MI or unstable angina
• Patients with uncontrolled diabetes
• Patients who present with a creatinine > 2.0mg/dl
• 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 (suprasellar, ambient, chiasmatic and quadrageminal)
• Vasospasm on admission as defined by angiographic evidence
• Patients with a coagulopathy that cannot be reversed per the professional discretion of the investigator
• Thrombocytopenia def. platelet count < 100,000
• Patients on low molecular weight heparin e.g., Lovenox
• Patients on Clopidogrel bisulfate (Plavix) or other chronic platelet inhibitors
• Patients with a documented history of cirrhosis
• Patients who will be managed with supportive care rather than intervention
• Obstructive hydrocephalus i.e., non-communicating
• Pregnancy
• History of posterior fusion hardware that would interfere with placement of the catheter
• Pre-existing Lumbar Drain
• Local skin infections or eruptions over the puncture site
• Signs of systemic infection/sepsis or pneumonia
• Lumbar puncture within 6 hours
• Concurrent participation in another study which is not observational or retrospective in nature without prior approval from the Sponsor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group	Device: Spinal catheter insertion with extracorporeal filtration of CSF; Extracorporeal filtration of CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device/System Safety - Adverse events related to the filtration procedure	Adverse events related to the filtration procedure	30 days
Adverse events related to the system catheter insertion	Nerve or tissue damage related to catheter insertion	30 days

Collaborators and Investigators

• Sponsor: Minnetronix
• Investigators: Study Director: Julie Messer, Minnetronix

Publications and helpful links

General Publications

• Blackburn SL, Grande AW, Swisher CB, Hauck EF, Jagadeesan B, Provencio JJ. Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter (PILLAR). Stroke. 2019 Sep;50(9):2558-2561. doi: 10.1161/STROKEAHA.119.025399. Epub 2019 Jul 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2017
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: DK-0000-001-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes