Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter (PILLAR)

Abstract

Background and Purpose- The PILLAR (Extracorporeal Filtration of Subarachnoid Hemorrhage via Spinal Catheter) study is a first-in-human trial of cerebrospinal fluid (CSF) filtration in aneurysmal subarachnoid hemorrhage. The study evaluates the safety and feasibility of a novel filtration system to rapidly remove blood and blood breakdown products from CSF after securement of a ruptured aneurysm. Methods- Patients with aneurysmal subarachnoid hemorrhage had a dual-lumen lumbar, intrathecal catheter placed after aneurysm securement and received up to 24 hours of CSF filtration (neurapheresis therapy). The catheter aspirated blood-contaminated CSF from the lumbar cistern and returned filtered CSF to the thoracic subarachnoid space. Neuro checks were performed q2 hours, and CSF samples were collected for cell counts, total protein, and gram stain. Computed tomography scans were acquired at baseline and post-filtration. Clinical follow-up occurred at 2 weeks and 30 days. Results- Thirteen patients had a catheter placed (mean time 24:13 hours after ictus). The system processed 632.0 mL (180.6-1447.6 mL) CSF in 15:07 hours (5:32-24:00 hours) of filtration. The mean initial CSF red blood cell count, 2.78×105 cells/µL, reduced to 1.17×105 cells/µL after filtration (52.9% reduction), and total protein reduced 71%. Independent analysis of baseline and postfiltration computed tomographies found notable cisternal blood decrease, with 46.5% mean Hijdra Score reduction. Three mild, anticipated adverse events were reported. Conclusions- The initial safety and feasibility of Neurapheresis therapy in aneurysmal subarachnoid hemorrhage demonstrated the potential to safely filter CSF and remove blood and blood byproducts. Future studies are warranted. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT0287263.

Trial registration: ClinicalTrials.gov NCT02872636.

Keywords: aneurysm, ruptured; catheters; cell counts; subarachnoid hemorrhage; tomography.

Conflict of interest statement

Conflict(s)-of-Interest/Disclosure(s):

The PILLAR clinical trial is supported by Minnetronix Inc and all authors received support for approved study related costs. Dr. Blackburn has no relevant conflicts; his effort is supported through NIH K23NS106054. Dr. Grande, Dr. Hauck, and Dr. Provencio have no conflicts. Dr. Swisher receives speaker’s honorarium from USB and Eisai Pharmaceuticals. Dr. Jagadeesan is a consultant for Microvention and Medtronic.

Figures

Figure 1:

Schematic of the Neurapheresis System.

Figure 2:

Demonstrated reduction of blood in the CSF after Neurapheresis therapy based on imaging analysis (A) and CSF sample analysis for red blood cell counts (B) and total protein (C). Box plots indicate the median, 25th and 75th percentile.