NCT02872636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

August 5, 2016

Last Update Submit

August 12, 2019

Conditions

Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (2)

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

    Adverse events related to the filtration procedure

    30 days

  • Adverse events related to the system catheter insertion

    Nerve or tissue damage related to catheter insertion

    30 days

Study Arms (1)

Treatment Group

EXPERIMENTAL
Device: Spinal catheter insertion with extracorporeal filtration of CSF

Interventions

Spinal catheter insertion with extracorporeal filtration of CSFDEVICE

Extracorporeal filtration of CSF

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 31345133DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Messer

    Minnetronix

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 19, 2016

Study Start

March 23, 2017

Primary Completion

April 16, 2018

Study Completion

August 31, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)