FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

NCT ID: NCT03607825

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-25
• Study Completion Date: 2021-02-17

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.

Conditions

Subarachnoid Hemorrhage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neurapheresis System

CSF filtration

Group Type: EXPERIMENTAL

Neurapheresis System

Intervention Type: DEVICE

CSF filtration system and lumbar catheter

Interventions

Neurapheresis System

CSF filtration system and lumbar catheter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minnetronix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida

Gainesville, Florida, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mount Sinai

New York, New York, United States

Memorial Hermann

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R1.0 11July18

Identifier Type: -

Identifier Source: org_study_id