FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

Subarachnoid Hemorrhage Clinical Trial

— PILLAR-XT  

Official title:

ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607825
• Other study ID #: R1.0 11July18
• Status: Completed
• Phase: N/A
• Start date: December 25, 2018
• Est. completion date: February 17, 2021

Study information

• Verified date: June 2021
• Source: Minnetronix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 17, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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 > 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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Neurapheresis System
CSF filtration system and lumbar catheter

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	Memorial Hermann	Houston	Texas
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Minnetronix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Cisternal Blood From Enrollment to Catheter Removal	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).	Enrollment to Catheter Removal (Immediately post treatment)
Secondary	Mean Change in Red Blood Cells From Before to After the Treatment Period.	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.	Catheter Insertion to Catheter Removal (Immediately post treatment)
Secondary	Mean Change in Total Protein From Before to After the Treatment Period	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.	Catheter Insertion to Catheter Removal (Immediately post treatment)