Clinical trial NCT03607825: FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
Official title: ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: aneurysmal
Lead sponsor: Minnetronix
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: The PILLAR-XT study is designed to further confirm safety and characterize efficacy of Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and does not detract from the established care pathways, or deny enrolled subjects proven therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators who are already trained in the treatment and care of SAH patients and insertion/management of lumbar drains.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change in Cisternal Blood From Enrollment to Catheter Removal
timeFrame: Enrollment to Catheter Removal (Immediately post treatment)
Secondary outcomes:
measure: Mean Change in Red Blood Cells From Before to After the Treatment Period.
timeFrame: Catheter Insertion to Catheter Removal (Immediately post treatment)
measure: Mean Change in Total Protein From Before to After the Treatment Period
timeFrame: Catheter Insertion to Catheter Removal (Immediately post treatment)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
Study officials:
References: