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| Name | Class |
|---|---|
| IRRAS | INDUSTRY |
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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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRRAflow device | All patients enrolled into the study will undergo treatment with the IRRAflow device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRRAflow® CNS (Active Fluid Exchange) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual blood volume by post bleed 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) | Post-procedure day 5 |
| Utility weighted modified Rankin Score | 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 | End of study, at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of blood clearance | Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes | Immediately before and after the procedure |
| Direct hospitalization costs | Direct hospitalization costs will be determined based on the hospital-reported cost of care for the entirety of the patient's hospital stay |
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Inclusion criteria:
Exclusion criteria:
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The patient population for this study will be comprised of up to 250 patients with primary diagnosis of intracranial hemorrhage (SAH, ICH, IVH, SDH), ventriculitis, or intracranial abscess.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sukaina Davdani | Contact | (212) 241-2524 | Sukaina.Davdani@mountsinai.org | |
| Sydney Edwards | Contact | (212) 241-2524 | Sydney.Edwards@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kellner | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Nicholas Brandmeir | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on its cloud-based system.
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Discharge, up to 7 days post procedure |
| NSICU Length of Stay | Hospital quality metrics will include length of neonatal surgery intensive care unit (NSICU) stay in days | Discharge, up to 7 days post procedure |
| Hospital Length of Stay (LOS) | Hospital quality metrics will include length of hospital stay in days | Discharge, up to 7 days post procedure |
| Proportion of participants needing a shunt | Proportion of participants needing a shunt will be calculated to determine how many patients needed a shunt to treat their hydrocephalus | Discharge, up to 7 days post procedure |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |