Intraventricular Catheter System for IVH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Conditions
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Intraventricular Hemorrhage (IVH)

Intervention / Treatment
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* Device: IRRAflow® Active Fluid Exchange System
* Device: Traditional extraventricular drain
* Procedure: Non-contrast head CTs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 years of age Intraventricular hemorrhage documented on head CT or MRI scan Need of cerebrospinal fluid drainage Indication for active treatment evaluated by the treating physicians Signed informed consent obtained by patient or Legal Authorized Representative Treatment possible within 72 hours of ictus Exclusion Criteria: Patient has fixed and dilated pupils Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The IRRAflow® System is an active fluid exchange system in which intracranial pressure (ICP) monitoring, active controlled irrigation and passive drainage are combined in one system. The system consists of 3 items; control unit (i) and two sterile disposable parts: (ii) Intelligent Digital Cassette (Tube Set) and (iii) dual-lumen Catheter.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRRAflow with Active Fluid Exchange arm<br>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<br>* 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.<br>* Other names: IRRAflow® CNS System;Procedure: Non-contrast head CTs<br>* 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.<br>|
| Active Comparator: Retrospective analysis of traditional external ventricular drains<br>The retrospective analysis will be performed on the last 60 traditional external ventricular drains. | Device: Traditional extraventricular drain<br>* The retrospective analysis will be performed on the last 60 traditional external ventricular drains.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual blood volume | Residual blood volume on post bleed day 5 | At day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events | Number of serious adverse events | up to 48 hours post-procedure | 
| Hospital quality metrics | Length of stay in the NSICU as a quality metrics | up to 48 hours post-procedure | 
| Length of stay in the NSICU | Length of hospital stay in the as a quality metrics | up to 48 hours post-procedure | 
| Direct hospitalization costs | Direct hospitalization costs | up to 48 hours post-procedure |