Subarachnoid HemorrhagePILLAR-XTNCT03607825
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension
A study testing Neurapheresis System in people with Subarachnoid Hemorrhage, run by Minnetronix at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Neurapheresis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Dec 2018to 17 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Florida
Gainesville, Florida, 32611
Memorial Hermann
Houston, Texas, 77001
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai
New York, New York, 10029
About this study
Official title: ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
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).
Read the detailed 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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Neurapheresis System
- Keywords
- aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurapheresis SystemDevice
CSF filtration system and lumbar catheter
| Study group | Role | What they receive |
|---|---|---|
| Neurapheresis System | Experimental | CSF filtration Receives: Device: Neurapheresis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Enrollment to Catheter Removal (Immediately post treatment)
Secondary outcomes (2)
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.
Measured: Catheter Insertion to Catheter Removal (Immediately post treatment)
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.
Measured: Catheter Insertion to Catheter Removal (Immediately post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start25 Dec 2018
- Primary completion11 Jan 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnetronix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607825
- Sponsor's protocol ID
- R1.0 11July18
- Acronym
- PILLAR-XT
- Status last verified
- Jun 2021
- First submitted
- 23 Jul 2018
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExtracorPoreal FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR EXTension
- ClinicalTrials.gov ID
- NCT03607825
- Acronym / sponsor ID
- PILLAR-XT / R1.0 11July18
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- aneurysmal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- MinnetronixIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurapheresis System | Experimental | Device: Neurapheresis SystemCSF filtration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurapheresis SystemCSF filtration system and lumbar catheter | Device | Neurapheresis System |
Primary outcome
Mean Change in Cisternal Blood From Enrollment to Catheter Removal
Time frame: Enrollment to Catheter Removal (Immediately post treatment)
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).
2 secondary outcomes
Mean Change in Red Blood Cells From Before to After the Treatment Period.
Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)
Mean Change in Total Protein From Before to After the Treatment Period
Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurapheresis System in people with Subarachnoid Hemorrhage, run by Minnetronix at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Cisternal Blood From Enrollment to Catheter Removal (time frame: Enrollment to Catheter Removal (Immediately post treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.