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Trial record 1 of 2 for:    pillar | Subarachnoid Hemorrhage
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Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter (PILLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02872636
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Minnetronix

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Device: Spinal catheter insertion with extracorporeal filtration of CSF Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group Device: Spinal catheter insertion with extracorporeal filtration of CSF
Extracorporeal filtration of CSF


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872636


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Memorial Hermann
Houston, Texas, United States, 77030
Sponsors and Collaborators
Minnetronix
Investigators
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Study Director: Julie Messer Minnetronix
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Minnetronix
ClinicalTrials.gov Identifier: NCT02872636    
Other Study ID Numbers: DK-0000-001-306
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases