Recruiting NCT05970549

Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

No phase Interventional Intraventricular Hemorrhage (IVH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: IRRAflow® Active Fluid Exchange System, Traditional extraventricular drain, Non-contrast head CTs.
Who it may be relevant to: Registry conditions: Intraventricular Hemorrhage (IVH). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
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Official title

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Overview

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.

Interventions

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 a
Device Traditional extraventricular drain
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
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

Primary outcome measures

Residual blood volume [Time frame: At day 5]

Secondary outcome measures (4)

Serious adverse events [Time frame: up to 48 hours post-procedure]
Hospital quality metrics [Time frame: up to 48 hours post-procedure]
Length of stay in the NSICU [Time frame: up to 48 hours post-procedure]
Direct hospitalization costs [Time frame: up to 48 hours post-procedure]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 1 center

Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT05970549 · STUDY-21-01815

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗