Intraventricular Catheter System for IVH

Not Applicable

Recruiting

• Conditions: Intraventricular Hemorrhage (IVH)
• Interventions: Device: IRRAflow® Active Fluid Exchange System; Device: Traditional extraventricular drain; Procedure: Non-contrast head CTs

• Registration Number: NCT05970549
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Study Start: 2022-06-14
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRRAflow with Active Fluid Exchange arm	IRRAflow® Active Fluid Exchange System	The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.
IRRAflow with Active Fluid Exchange arm	Non-contrast head CTs	The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.
Retrospective analysis of traditional external ventricular drains	Traditional extraventricular drain	The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Primary Outcome Measures

Name	Time	Method
Residual blood volume	At day 5	Residual blood volume on post bleed day 5

Secondary Outcome Measures

Name	Time	Method
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
Serious adverse events	up to 48 hours post-procedure	Number of serious adverse events
Direct hospitalization costs	up to 48 hours post-procedure	Direct hospitalization costs

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States