Trial Outcomes & Findings for FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension (NCT NCT03607825)
NCT ID: NCT03607825
Last Updated: 2022-10-06
Results Overview
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).
COMPLETED
NA
33 participants
Enrollment to Catheter Removal (Immediately post treatment)
2022-10-06
Participant Flow
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determined to no longer meet inclusion criteria after they were consented (n=4 Intent to Treat) and were immediately withdrawn.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subjects were consented and the catheter placement was attempted but was not successful (n=2 Attempt to Treat) and were withdrawn after 2-day follow-up.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.
Participant milestones
| Measure |
Neurapheresis System
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
Baseline characteristics by cohort
| Measure |
Neurapheresis System
n=33 Participants
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Age, Continuous
|
49.9 years
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Sex: Female, Male
Female
|
22 Participants
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Sex: Female, Male
Male
|
7 Participants
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=33 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=33 Participants
|
|
Height
|
166.7 cm
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Weight
|
76.1 kg
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
History of Smoking
|
16 Participants
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
History of Hypertension
|
18 Participants
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Prior History of Brain Injury Treatment
|
2 Participants
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
WFNS Grading System
|
2 Units on a Scale
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Hunt & Hess Scale
|
3 units on a scale
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Glasgow Coma Scale
|
14 units on a scale
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
|
Modified Fisher Grade
|
3 units on a scale
n=29 Participants • In this protocol there were 4 intent to treat patients. Per protocol, the intent to treat patients were not included in this measure
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Neurapheresis System
n=26 Participants
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Mean Change in Cisternal Blood From Enrollment to Catheter Removal
|
-64.7 percent change
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Neurapheresis System
n=26 Participants
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Mean Change in Red Blood Cells From Before to After the Treatment Period.
|
-85.8 percent change
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Neurapheresis System
n=26 Participants
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Mean Change in Total Protein From Before to After the Treatment Period
|
-82.4 percent change
Standard Deviation 16.1
|
Adverse Events
Neurapheresis System
Serious adverse events
| Measure |
Neurapheresis System
n=29 participants at risk
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Nervous system disorders
Diencephalic Herniation
|
3.4%
1/29 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Neurapheresis System
n=29 participants at risk
CSF filtration
Neurapheresis System: CSF filtration system and lumbar catheter
|
|---|---|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 2 • 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.
|
|
Nervous system disorders
Back Pain
|
6.9%
2/29 • Number of events 2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER