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Completed

NCT Number: NCT03607825

FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

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).

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurapheresis System

Device

CSF filtration system and lumbar catheter

Primary outcomes

  1. Mean Change in Cisternal Blood From Enrollment to Catheter Removal

    Time frame: Enrollment to Catheter Removal (Immediately post treatment)

    Mean Change in Cisternal Blood measured by the Hijdra Score as Documented by CT, represented as a percent change. The Hijdra Score evaluates 10 cisterns and fissures within the brain for the quantity of blood present on a 0-3 scale. 0 means no blood present, 1 is a small amount, 2 is moderately filled, and 3 is completely filled. The 10 scores are added up. A Hijdra Score of 0 means no blood present (normal) and a Hijdra Score of 30 means all the cisterns and fissures are completely filled with blood (poor outcome).

Secondary outcomes

  1. Mean Change in Red Blood Cells From Before to After the Treatment Period.

    Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)

    Mean Change in Red Blood Cells as measured by CSF analysis of RBCs, represented as a percent change. The RBCs are measured in the CSF in quantity of RBC (10^6) per mm^3. The change is calculated using the first available RBC measurement (at either Catheter Insertion or after 1 hour of CSF Filtration, if first measurement unavailable) compared to the last available RBC measurement before the catheter was removed.

  2. Mean Change in Total Protein From Before to After the Treatment Period

    Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)

    Mean Change in Total Protein as measured by CSF analysis of RBCs, represented as a percent change. The Total Protein is measured in the CSF in quantity of mg/dL. The change is calculated using the first available Total Protein measurement (at either Catheter Insertion or after 1 hour of CSF Filtration, if first measurement unavailable) compared to the last available Total Protein measurement before the catheter was removed.

Sponsors and collaborators

Lead sponsor

Minnetronix

Industry

Registry information

Official study title

ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension

Acronym: PILLAR-XT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2018
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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