Skip to main content
OpenTrials
Completed

NCT Number: NCT02872636

Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal catheter insertion with extracorporeal filtration of CSF

Device

Extracorporeal filtration of CSF

Primary outcomes

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

    Time frame: 30 days

    Adverse events related to the filtration procedure

  2. Adverse events related to the system catheter insertion

    Time frame: 30 days

    Nerve or tissue damage related to catheter insertion

Sponsors and collaborators

Lead sponsor

Minnetronix

Industry

Registry information

Acronym: PILLAR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2016
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.