Protocol Summary

Protocol No.: OCR19685

Protocol Title.: FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

Principal Investigator: Babi, Marc

Objective: 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).

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.

Phase: Phase II

Age: 18 Years - 70 Years

Gender: All

Treatment:

Experimental: Neurapheresis System
CSF filtration

Detailed Eligibility:

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 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
- 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

Applicable Conditions:

  • Supratentorial Intracerebral Hemorrhage
  • Participation Institution:

  • No UF Health MRN : Cyrus Saleem
  • UF Gainesville : Cyrus Saleem
  • UF Jacksonville : Cyrus Saleem
  • Contact:
    Cyrus Saleem
    Email: cyrus.saleem@neurology.ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT03607825