Intraventricular Catheter System for IVH

Intraventricular Hemorrhage (IVH) Clinical Trial

— DIVE  

Official title:

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970549
• Other study ID #: STUDY-21-01815
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Christopher P Kellner, MD
• Phone: 212-241-2606
• Email: christopher.kellner[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage (IVH)

Intervention

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 any issues or questions should they arise.
• 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 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	IRRAS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual blood volume	Residual blood volume on post bleed day 5	At day 5
Secondary	Serious adverse events	Number of serious adverse events	up to 48 hours post-procedure
Secondary	Hospital quality metrics	Length of stay in the NSICU as a quality metrics	up to 48 hours post-procedure
Secondary	Length of stay in the NSICU	Length of hospital stay in the as a quality metrics	up to 48 hours post-procedure
Secondary	Direct hospitalization costs	Direct hospitalization costs	up to 48 hours post-procedure