Subarachnoid Hemorrhage
Conditions
Keywords
aneurysmal
Brief 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).
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.
Interventions
DEVICENeurapheresis System
CSF filtration system and lumbar catheter
Sponsors
Minnetronix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Cisternal Blood From Enrollment to Catheter Removal | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Red Blood Cells From Before to After the Treatment Period. | Catheter Insertion to Catheter Removal (Immediately post treatment) | 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. |
| Mean Change in Total Protein From Before to After the Treatment Period | Catheter Insertion to Catheter Removal (Immediately post treatment) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Neurapheresis System CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Neurapheresis System |
|---|---|
| Age, Continuous | 49.9 years |
| Glasgow Coma Scale | 14 units on a scale |
| Height | 166.7 cm |
| History of Hypertension | 18 Participants |
| History of Smoking | 16 Participants |
| Hunt & Hess Scale | 3 units on a scale |
| Modified Fisher Grade | 3 units on a scale |
| Prior History of Brain Injury Treatment | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 7 Participants |
| Weight | 76.1 kg |
| WFNS Grading System | 2 Units on a Scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 4 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
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).
Time frame: Enrollment to Catheter Removal (Immediately post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurapheresis System | Mean Change in Cisternal Blood From Enrollment to Catheter Removal | -64.7 percent change | Standard Deviation 19.8 |
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.
Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurapheresis System | Mean Change in Red Blood Cells From Before to After the Treatment Period. | -85.8 percent change | Standard Deviation 20.8 |
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.
Time frame: Catheter Insertion to Catheter Removal (Immediately post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurapheresis System | Mean Change in Total Protein From Before to After the Treatment Period | -82.4 percent change | Standard Deviation 16.1 |