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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurapheresis System | Experimental | CSF filtration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurapheresis System | Device | CSF filtration system and lumbar catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Enrollment to Catheter Removal (Immediately post treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| University of Minnesota |
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Four subjects were consented but catheter placement was not attempted as they were determined to no longer meet inclusion criteria after they were consented (n=4 Intent to Treat) and were immediately withdrawn. Two subjects were consented and the catheter placement was attempted but was not successful (n=2 Attempt to Treat) and were withdrawn after 2-day follow-up. The remaining subjects (N=27) had successful catheter placement, had CSF Filtration and were followed for 30 days per the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurapheresis System | CSF filtration Neurapheresis System: CSF filtration system and lumbar catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurapheresis System | CSF filtration Neurapheresis System: CSF filtration system and lumbar catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | percent change | Enrollment to Catheter Removal (Immediately post treatment) |
|
enrollment through 30 day follow-up
PILLAR-XT did not track all-cause AEs or AEs related to SOC or the SAH clinical pathway e.g., re-bleed, deep vein thrombosis, skin breakdown etc. Study required event reporting is limited to AEs directly related to the investigational catheter, investigational system or Neurapheresis procedure, or study required element (such as CSF sampling). In cases where the event may have an attributable dual causality the center should report the event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurapheresis System | CSF filtration Neurapheresis System: CSF filtration system and lumbar catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diencephalic Herniation | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Minnetronix Neuro | 651-917-4060 | info@cerevention.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2020 | Jul 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | Catheter Insertion to Catheter Removal (Immediately post treatment) |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Memorial Hermann | Houston | Texas | 77001 | United States |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Mean | Full Range | cm |
|
| Weight | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Mean | Full Range | kg |
|
| History of Smoking | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Count of Participants | Participants |
|
| History of Hypertension | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Count of Participants | Participants |
|
| Prior History of Brain Injury Treatment | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Count of Participants | Participants |
|
| WFNS Grading System | The WFNS (World Federation of Neurological Surgeons) Grading System For Subarachnoid Hemorrhage combines the Glasgow Coma Scale in the presence (+) or absence (-) of Motor Deficit to create a 1-5 Grade: GCS 15, Motor Deficit+ = WFNS Grade 1 GCS 13-14, Motor Deficit- = WFNS Grade 2 GCS 13-14, Motor Deficit+ = WFNS Grade 3 GCS 7-12, Motor Deficit + or - = WFNS Grade 4 GCS 3-6, Motor Deficit + or - = WFNS Grade 5 A higher WFNS grade (e.g. WFNS Grade 5) is associated with higher mortality rates / worse outcomes. | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Median | Full Range | Units on a Scale |
|
| Hunt & Hess Scale | The Hunt and Hess (H&H) Scale is a clinical grading system of subarachnoid hemorrhage that ranges from 1 to 5. H&H 1: Asymptomatic, mild headache, slight nuchal rigidity H&H 2: Moderate to severe headache, nuchal rigidity, no neurologic deficit other than cranial nerve palsy H&H 3: Drowsiness/confusion, mild focal neurologic deficit H&H 4: Stupor, moderate-sever hemiparesis H&H 5: Coma, decerebrate posturing | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Median | Full Range | units on a scale |
|
| Glasgow Coma Scale | The Glasgow Coma Scale (GCS) is used to describe the level of consciousness after a brain injury. It combines scores of 3 activities: Eye Opening, Motor Response, and Verbal Response. Eye Opening is scored from 1-4, Motor Response from 1-6, and Verbal Response from 1-5. The minimum GCS score is 3 and the maximum is 15. For example, a severe brain injury is GCS 8 or less, Moderate is GCS 9-12, and Mild is GCS 13-15 | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Median | Full Range | units on a scale |
|
| Modified Fisher Grade | The modified Fisher Grade Scale (mFS) in a means of stating the severity of an aneurysmal subarachnoid hemorrhage based on the amount and type of blood as measured on CT. The scale ranges from 0-4. mFS = 0: No SAH, or IVH mFS = 1: Thin diffuse or focal SAH, no IVH mFS = 2: Thin diffuse or local SAH, with IVH mFS = 3: Thick focal or diffuse SAH, no IVH mFS = 4: Thick local or diffuse SAH with IVH | In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure | Median | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent change | Catheter Insertion to Catheter Removal (Immediately post treatment) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent change | Catheter Insertion to Catheter Removal (Immediately post treatment) |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| 4 |
| 29 |
| Back Pain | Nervous system disorders | Non-systematic Assessment |
|
PI agrees that first publication of the results of the Study shall be made in conjunction with the presentation of a joint multi-center publication. PI may publish individually if multi-center publication is published, or no multi-center publication is published within 12 months of conclusion, or Sponsor confirms in writing there will be no multi-center publication. If no multi-center publication within 12 months, Sponsor will provide PI access to aggregate data.
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |