Clinical trial NCT02872636: Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Official title: Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Minnetronix
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Device/System Safety - Adverse events related to the filtration procedure
timeFrame: 30 days
measure: Adverse events related to the system catheter insertion
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
Study officials:
affiliation: Minnetronix
name: Julie Messer
role: STUDY_DIRECTOR
References:
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.