Intraventricular Catheter System for IVH (DIVE)

Mount Sinai Health System

Status: Enrolling

Conditions: Intraventricular Hemorrhage (IVH)

Treatments: Device: IRRAflow® Active Fluid Exchange System; Procedure: Non-contrast head CTs; Device: Traditional extraventricular drain

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05970549

STUDY-21-01815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

IRRAflow with Active Fluid Exchange arm

Experimental group

Description:

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

Treatment:

Procedure: Non-contrast head CTs

Device: IRRAflow® Active Fluid Exchange System

Retrospective analysis of traditional external ventricular drains

Active Comparator group

Description:

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Treatment:

Device: Traditional extraventricular drain