FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension (PILLAR-XT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03607825 |
Recruitment Status :
Completed
First Posted : July 31, 2018
Last Update Posted : June 4, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subarachnoid Hemorrhage | Device: Neurapheresis System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension |
Actual Study Start Date : | December 25, 2018 |
Actual Primary Completion Date : | January 11, 2021 |
Actual Study Completion Date : | February 17, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Neurapheresis System
CSF filtration
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Device: Neurapheresis System
CSF filtration system and lumbar catheter |
- Mean Change in Cisternal Blood [ Time Frame: Immediately post treatment ]Documented by CT
- Mean Change in Red Blood Cells [ Time Frame: Immediately post treatment ]CSF analysis of RBCs
- Mean Change in Total Protein [ Time Frame: Immediately post treatment ]CSF analysis of Total Protein

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607825
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32611 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Mount Sinai | |
New York, New York, United States, 10029 | |
United States, Texas | |
Memorial Hermann | |
Houston, Texas, United States, 77001 |
Responsible Party: | Minnetronix |
ClinicalTrials.gov Identifier: | NCT03607825 |
Other Study ID Numbers: |
R1.0 11July18 |
First Posted: | July 31, 2018 Key Record Dates |
Last Update Posted: | June 4, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
aneurysmal |
Subarachnoid Hemorrhage Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |