Intraventricular Catheter System for IVH (DIVE)

DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher P Kellner, MD; Phone Number: 212-241-2606; Email: christopher.kellner@mountsinai.org
• Study Contact Backup: Name: Trevor Hardigan, MD PhD; Phone Number: 212-241-2606; Email: trevor.hardigan@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Christopher P Kellner, MD; Phone Number: 212-241-2606; Email: christopher.kellner@mountsinai.org
      • Contact: Trevor Hardigan, MD PhD; Phone Number: 212-241-2606; Email: trevor.hardigan@mountsinai.org
      • Principal Investigator: Christopher P Kellner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IRRAflow with Active Fluid Exchange arm; The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.	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.; Other Names: IRRAflow® CNS System; 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.
Active Comparator: Retrospective analysis of traditional external ventricular drains; The retrospective analysis will be performed on the last 60 traditional external ventricular drains.	Device: Traditional extraventricular drain; The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual blood volume	Residual blood volume on post bleed day 5	At day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Number of serious adverse events	up to 48 hours post-procedure
Hospital quality metrics	Length of stay in the NSICU as a quality metrics	up to 48 hours post-procedure
Length of stay in the NSICU	Length of hospital stay in the as a quality metrics	up to 48 hours post-procedure
Direct hospitalization costs	Direct hospitalization costs	up to 48 hours post-procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: IRRAS
• Investigators: Principal Investigator: Christopher P Kellner, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: STUDY-21-01815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to minimize any privacy risks to the patients participating, IPD data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes