DIVE: Intraventricular Catheter System for IVH
Study Details
Study Description
Brief Summary
The purpose of this research study is to evaluate the safety and outcomes associated with the use of IRRAflow® System catheters in externally draining intracranial fluid to reduce intracranial pressure. This study will be comparing the IRRAflow® system to standard of care catheters used in the same procedure. The IRRAflow® system is FDA approved for this procedure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Intracranial hemorrhagic conditions can rapidly cause brain damage and often considered life- threatening. Of these, Intracerebral hemorrhagic (ICH) is the most common type of hemorrhagic stroke and is associated with higher rates of morbidity and mortality than all stroke subtypes.
Management of hemorrhagic patients is typically orchestrated by neurosurgeons and neuro-intensivists. Comprehensive care should include surveillance and monitoring of Intra Cranial Pressure (ICP), Cerebral Perfusion Pressure (CPP), and hemodynamic function. Furthermore, prevention of infection, complications of immobility through positioning and mobilization within physiological tolerance play an important role in optimizing outcomes after ICH.
There are multiple approaches to facilitating Cerebrospinal Fluid (CSF) drainage and monitor ICP. Routinely, intracranial pressure is measured by use of devices inserted into the brain parenchyma or cerebral ventricles. A Ventricular Catheter (VC) inserted into the lateral ventricle allows for drainage of CSF to help reduce ICP. Although CSF drainage is a vital sequence in patient management, there are reported risks including infection and limitations related to erroneous readings associated with current ICP monitors. Physicians lack the appropriate tools to employ active intermittent aspiration and drainage with continuous ICP monitoring.
The current clinical study is being initiated to evaluate the hypothesis that active irrigation by IRRAflow will reduce the time needed for clearance of intraventricular blood from intraventricular space.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IRRAflow with Active Fluid Exchange arm The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. |
Device: IRRAflow® Active Fluid Exchange System
All patients in the prospective arm of the study who met the study criteria and consent will be enrolled in the IRRAflow with Active Fluid Exchange arm.
Insertion of the IRRaflow catheter will be performed by neurosurgical attendings and residents who are privileged to place external ventricular drains and who have be instructed on how to appropriately connect the inserted IRRAflow catheter to the system. The on-site IRRAflow instructor will be present and available at all time to assist with any issues or questions should they arise.
Other Names:
Procedure: Non-contrast head CTs
Non-contrast head CTs will be performed at least every 48 hours to document effectiveness. This frequency is standard, if not more frequent as necessary, for patients with external ventricular drainage and intraventricular hemorrhage. Scans are routinely obtained at this frequency to evaluate, for example: evacuation of hemorrhage, admission pathology, post-placement of catheters, any change in neurological exam, or after elevations in intracranial pressure. With these common CT scans we will be able to assess the efficacy of the IRRAflow catheter on the specified parameters. These scans are routinely performed due to this pathology and as such are covered as a necessity of the hospitalization by the insurance companies. MRI may be used in place of a CT scan if medically indicated as determined by the neurosurgical attending or neurocritical care attending according to standard of care for treatment of the neurological pathology.
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| Active Comparator: Retrospective analysis of traditional external ventricular drains The retrospective analysis will be performed on the last 60 traditional external ventricular drains. |
Device: Traditional extraventricular drain
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
|
Outcome Measures
Primary Outcome Measures
- Residual blood volume [At day 5]
Residual blood volume on post bleed day 5
Secondary Outcome Measures
- Serious adverse events [up to 48 hours post-procedure]
Number of serious adverse events
- Hospital quality metrics [up to 48 hours post-procedure]
Length of stay in the NSICU as a quality metrics
- Length of stay in the NSICU [up to 48 hours post-procedure]
Length of hospital stay in the as a quality metrics
- Direct hospitalization costs [up to 48 hours post-procedure]
Direct hospitalization costs
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >=18 years of age
-
Intraventricular hemorrhage documented on head CT or MRI scan
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Need of cerebrospinal fluid drainage
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Indication for active treatment evaluated by the treating physicians
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Signed informed consent obtained by patient or Legal Authorized Representative
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Treatment possible within 72 hours of ictus
Exclusion Criteria:
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Patient has fixed and dilated pupils
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Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10128 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
- IRRAS
Investigators
- Principal Investigator: Christopher P Kellner, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-21-01815