Back to resultsExtracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter (PILLAR)
Primary Purpose
Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal catheter insertion with extracorporeal filtration of CSF
Sponsored by
About this trial
This is an interventional basic science trial for Subarachnoid Hemorrhage
Eligibility 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
Sites / Locations
- University of Minnesota
- Duke University
- Thomas Jefferson University
- Memorial Hermann
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Outcomes
Primary Outcome Measures
Device/System Safety - Adverse events related to the filtration procedure
Adverse events related to the filtration procedure
Adverse events related to the system catheter insertion
Nerve or tissue damage related to catheter insertion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02872636
Brief Title
Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Acronym
PILLAR
Official Title
Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2017 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minnetronix
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Spinal catheter insertion with extracorporeal filtration of CSF
Intervention Description
Extracorporeal filtration of CSF
Primary Outcome Measure Information:
Title
Device/System Safety - Adverse events related to the filtration procedure
Description
Adverse events related to the filtration procedure
Time Frame
30 days
Title
Adverse events related to the system catheter insertion
Description
Nerve or tissue damage related to catheter insertion
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Messer
Organizational Affiliation
Minnetronix
Official's Role
Study Director
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31345133
Citation
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.
Results Reference
derived
Learn more about this trial
Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
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