Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter

Subarachnoid Hemorrhage Clinical Trial

— PILLAR  

Official title:

Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872636
• Other study ID #: DK-0000-001-306
• Status: Completed
• Phase: N/A
• Start date: March 23, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: August 2019
• Source: Minnetronix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this feasibility study is to demonstrate the safety and feasibility of using an investigational extracorporeal system and catheter to filter hemorrhagic cerebrospinal fluid (CSF) post subarachnoid hemorrhage (SAH) treatment, and reintroduce the CSF via the same catheter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: 18 years or older

• Informed consent by the patient or his/her legally authorized representative

• Modified Fisher Grade 2, 3, or 4

• Hunt & Hess I-III

• First aneurysmal SAH that has been confirmed by Angio, CTA or MRA

• Patient is = 48 hours post bleeding event

• World Federation of Neurosurgeons (WFNS) Grades I-IV and those Grade V patients who improve to Grade IV or less after ventriculostomy.

Exclusion Criteria:

• Patients with a SAH due to mycotic aneurysm or AV malformation

• Patients who present with an acute MI or unstable angina

• Patients with uncontrolled diabetes

• Patients who present with a creatinine > 2.0mg/dl

• 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 (suprasellar, ambient, chiasmatic and quadrageminal)

• Vasospasm on admission as defined by angiographic evidence

• Patients with a coagulopathy that cannot be reversed per the professional discretion of the investigator

• Thrombocytopenia def. platelet count < 100,000

• Patients on low molecular weight heparin e.g., Lovenox

• Patients on Clopidogrel bisulfate (Plavix) or other chronic platelet inhibitors

• Patients with a documented history of cirrhosis

• Patients who will be managed with supportive care rather than intervention

• Obstructive hydrocephalus i.e., non-communicating

• Pregnancy

• History of posterior fusion hardware that would interfere with placement of the catheter

• Pre-existing Lumbar Drain

• Local skin infections or eruptions over the puncture site

• Signs of systemic infection/sepsis or pneumonia

• Lumbar puncture within 6 hours

• Concurrent participation in another study which is not observational or retrospective in nature without prior approval from the Sponsor

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Spinal catheter insertion with extracorporeal filtration of CSF
Extracorporeal filtration of CSF

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Memorial Hermann	Houston	Texas
United States	University of Minnesota	Minneapolis	Minnesota
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Minnetronix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device/System Safety - Adverse events related to the filtration procedure	Adverse events related to the filtration procedure	30 days
Primary	Adverse events related to the system catheter insertion	Nerve or tissue damage related to catheter insertion	30 days