Subarachnoid HemorrhagePILLARNCT02872636
Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
A study testing Spinal catheter insertion with extracorporeal filtration of CSF in people with Subarachnoid Hemorrhage, run by Minnetronix at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Spinal catheter insertion with extracorporeal filtration of CSF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Mar 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University
Durham, North Carolina, 27705
Memorial Hermann
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Spinal catheter insertion with extracorporeal filtration of CSF
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal catheter insertion with extracorporeal filtration of CSFDevice
Extracorporeal filtration of CSF
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: Spinal catheter insertion with extracorporeal filtration of CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device/System Safety - Adverse events related to the filtration procedure
Adverse events related to the filtration procedure
Measured: 30 days
Adverse events related to the system catheter insertion
Nerve or tissue damage related to catheter insertion
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start23 Mar 2017
- Primary completion16 Apr 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnetronix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Messer, Study director, Minnetronix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872636
- Sponsor's protocol ID
- DK-0000-001-306
- Acronym
- PILLAR
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Blackburn SL, Grande AW, Swisher CB, Hauck EF, Jagadeesan B, Provencio JJ. Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter (PILLAR). Stroke. 2019 Sep;50(9):2558-2561. doi: 10.1161/STROKEAHA.119.025399. Epub 2019 Jul 26.
PubMed 31345133
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Filtration of Subarachnoid Hemorrhage Via Spinal Catheter
- ClinicalTrials.gov ID
- NCT02872636
- Acronym / sponsor ID
- PILLAR / DK-0000-001-306
- Conditions
- Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MinnetronixIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Spinal catheter insertion with extracorporeal filtration of CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| Spinal catheter insertion with extracorporeal filtration of CSFExtracorporeal filtration of CSF | Device | Treatment Group |
Primary outcome
Device/System Safety - Adverse events related to the filtration procedure
Time frame: 30 days
Adverse events related to the filtration procedure
Adverse events related to the system catheter insertion
Time frame: 30 days
Nerve or tissue damage related to catheter insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 31345133Blackburn SL, Grande AW, Swisher CB, Hauck EF, Jagadeesan B, Provencio JJ. Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter (PILLAR). Stroke. 2019 Sep;50(9):2558-2561. doi: 10.1161/STROKEAHA.119.025399. Epub 2019 Jul 26.
- 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.
Julie Messer study director
Minnetronix
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal catheter insertion with extracorporeal filtration of CSF 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 7 inclusion and 22 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 13 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Device/System Safety - Adverse events related to the filtration procedure (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02872636, which also lists 1 linked publication.
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 13 Aug 2019.