Intracranial Abscess, Intracranial Hemorrhage, Ventriculitis
Conditions
Brief summary
The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.
Detailed description
The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - \[Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)\], intracranial abscess, and ventriculitis. The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).
Interventions
DEVICEIRRAflow® CNS (Active Fluid Exchange) System
The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.
Sponsors
IRRAS
Christopher P Kellner
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years of age * Intracranial hemorrhage documented on head CT or MRI scan. * Indication for active fluid exchange evaluated by treating physician. * Signed informed consent obtained by patient or Legal Authorized Representative * Scheduled enrollment and treatment within 72 hours of last known well (LKW)
Exclusion criteria
* GCS ≤ 5 * Pregnancy * Fixed and dilated pupil * Life-threatening medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual blood volume by post bleed day 5 | Post-procedure day 5 | The residual blood volume at day 5 will be calculated to determine the efficacy of the IRRAflow system compared to other external ventricular drains (EVDs) |
| Utility weighted modified Rankin Score | End of study, at 6 months | Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. Scores range from 0 to 6, with 0 indicating no disability and 6 indicating death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NSICU Length of Stay | Discharge, up to 7 days post procedure | Hospital quality metrics will include length of neonatal surgery intensive care unit (NSICU) stay in days |
| Rate of blood clearance | Immediately before and after the procedure | Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes |
| Proportion of participants needing a shunt | Discharge, up to 7 days post procedure | Proportion of participants needing a shunt will be calculated to determine how many patients needed a shunt to treat their hydrocephalus |
| Hospital Length of Stay (LOS) | Discharge, up to 7 days post procedure | Hospital quality metrics will include length of hospital stay in days |
| Direct hospitalization costs | Discharge, up to 7 days post procedure | Direct hospitalization costs will be determined based on the hospital-reported cost of care for the entirety of the patient's hospital stay |
Countries
United States
Contacts
Primary ContactSukaina Davdani
Backup ContactSydney Edwards
Outcome results
None listed