FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
PILLAR-XT
ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
1 other identifier
interventional
33
1 country
4
Brief Summary
The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
December 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2021
CompletedResults Posted
Study results publicly available
October 6, 2022
CompletedOctober 6, 2022
June 1, 2021
2 years
July 23, 2018
July 19, 2022
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Cisternal Blood From Enrollment to Catheter Removal
Mean Change in Cisternal Blood measured by the Hijdra Score as Documented by CT, represented as a percent change. The Hijdra Score evaluates 10 cisterns and fissures within the brain for the quantity of blood present on a 0-3 scale. 0 means no blood present, 1 is a small amount, 2 is moderately filled, and 3 is completely filled. The 10 scores are added up. A Hijdra Score of 0 means no blood present (normal) and a Hijdra Score of 30 means all the cisterns and fissures are completely filled with blood (poor outcome).
Enrollment to Catheter Removal (Immediately post treatment)
Secondary Outcomes (2)
Mean Change in Red Blood Cells From Before to After the Treatment Period.
Catheter Insertion to Catheter Removal (Immediately post treatment)
Mean Change in Total Protein From Before to After the Treatment Period
Catheter Insertion to Catheter Removal (Immediately post treatment)
Study Arms (1)
Neurapheresis System
EXPERIMENTALCSF filtration
Interventions
Eligibility Criteria
You may qualify if:
- Modified Fisher Grade 2, 3 or 4
- Hunt \& Hess I-IV
- First aneurysmal SAH
- Patient is ≤ 48 hours post bleeding event
- World Federation of Neurosurgeons (WFNS) Grades I-IV
You may not qualify if:
- Pregnancy
- Patients with a SAH due to mycotic aneurysm or AV malformation
- Patients who present with an acute MI or unstable angina
- Imaging demonstrates supratentorial mass lesions \> or = 15 cc
- Imaging demonstrates \> or = 2 mm of mid-line-shift associated with infarction and or edema
- Effacement of the basilar cisterns
- Vasospasm on admission as defined by angiographic evidence
- Patients with a coagulopathy that cannot be reversed
- Thrombocytopenia def. platelet count \< 100,000
- Patients on low molecular weight heparin such as Lovenox
- Non-communicating Obstructive hydrocephalus
- Existing hardware that prevents accurate CT imaging
- Pre-existing Lumbar Drain
- Local skin infections or eruptions over the puncture site
- Signs of CNS systemic infection, sepsis or pneumonia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minnetronixlead
Study Sites (4)
University of Florida
Gainesville, Florida, 32611, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mount Sinai
New York, New York, 10029, United States
Memorial Hermann
Houston, Texas, 77001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Minnetronix Neuro
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 31, 2018
Study Start
December 25, 2018
Primary Completion
January 11, 2021
Study Completion
February 17, 2021
Last Updated
October 6, 2022
Results First Posted
October 6, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share