FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

Completed · Not applicable

Conditions studied: Subarachnoid Hemorrhage

In brief

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).

Key facts

Study ID

NCT03607825

Run by

Minnetronix

People needed

33

Starts

2018-12-25

Expected to finish

2021-02-17

Last updated by the study team

2022-10-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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