N/A
N=33
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
Subarachnoid Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT03607825 ↗Enrolled (actual)
33
Serious AEs
3.5%
Results posted
Oct 2022
Primary outcome: Primary: Mean Change in Cisternal Blood From Enrollment to Catheter Removal — -64.7 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neurapheresis System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Minnetronix
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Cisternal Blood From Enrollment to Catheter Removal |
-64.7 | — |
| SECONDARY Mean Change in Red Blood Cells From Before to After the Treatment Period. |
-85.8 | — |
| SECONDARY Mean Change in Total Protein From Before to After the Treatment Period |
-82.4 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03607825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.