Clinical trial NCT05970549: Intraventricular Catheter System for IVH
Official title: DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage (IVH)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: IRRAS
First posted: 2023-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Residual blood volume
timeFrame: At day 5
Secondary outcomes:
measure: Serious adverse events
timeFrame: up to 48 hours post-procedure
measure: Hospital quality metrics
timeFrame: up to 48 hours post-procedure
measure: Length of stay in the NSICU
timeFrame: up to 48 hours post-procedure
measure: Direct hospitalization costs
timeFrame: up to 48 hours post-procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christopher P Kellner, MD
role: PRINCIPAL_INVESTIGATOR
References: