Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter (PILLAR)

Minnetronix

Status

Completed

Conditions

Subarachnoid Hemorrhage

Treatments

Device: Spinal catheter insertion with extracorporeal filtration of CSF

Study type

Interventional

Funder types

Industry

Identifiers

NCT02872636

DK-0000-001-306

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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