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CompletedNCT02872636PILLARUpdated Aug 13, 2019

Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter

An interventional study of Spinal catheter insertion with extracorporeal filtration of CSF in Subarachnoid Hemorrhage, sponsored by Minnetronix. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by Minnetronix · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Apr 2018, 8 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Subarachnoid Hemorrhage
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's enrollment of 15 is below the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Minnetronix is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Treatment Group

    Device: Spinal catheter insertion with extracorporeal filtration of CSF

Interventions

  • DeviceSpinal catheter insertion with extracorporeal filtration of CSF

    Extracorporeal filtration of CSF

06

What researchers measure

Primary outcomes

  1. Device/System Safety - Adverse events related to the filtration procedure

    Adverse events related to the filtration procedure

    Time frame: 30 days

  2. Adverse events related to the system catheter insertion

    Nerve or tissue damage related to catheter insertion

    Time frame: 30 days

07

Study locations

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

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. PubMed 31345133 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02872636
Lead sponsor
Minnetronix
Responsible party
Sponsor
First posted
Aug 19, 2016
Start date
Mar 23, 2017
Primary completion
Apr 16, 2018
Completion
Aug 31, 2018
Last update
Aug 13, 2019

Study contacts

Julie Messer
study director · Minnetronix

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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