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Intraventricular Catheter System for IVH (DIVE)

Primary Purpose

Intraventricular Hemorrhage (IVH)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IRRAflow® Active Fluid Exchange System
Traditional extraventricular drain
Non-contrast head CTs
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage (IVH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRRAflow with Active Fluid Exchange arm

Retrospective analysis of traditional external ventricular drains

Arm Description

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Outcomes

Primary Outcome Measures

Residual blood volume
Residual blood volume on post bleed day 5

Secondary Outcome Measures

Serious adverse events
Number of serious adverse events
Hospital quality metrics
Length of stay in the NSICU as a quality metrics
Length of stay in the NSICU
Length of hospital stay in the as a quality metrics
Direct hospitalization costs
Direct hospitalization costs

Full Information

First Posted
July 24, 2023
Last Updated
July 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
IRRAS
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1. Study Identification

Unique Protocol Identification Number
NCT05970549
Brief Title
Intraventricular Catheter System for IVH
Acronym
DIVE
Official Title
DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
July 3, 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
IRRAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage (IVH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
There will be no masking involved. The proposed study is a single center retrospective and prospective cohort, controlled, single-center, phase 1 study evaluating the safety and radiographic outcomes associated use of the IRRAS catheter compared to standard of care external ventricular drains.
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRRAflow with Active Fluid Exchange arm
Arm Type
Experimental
Arm Description
The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.
Arm Title
Retrospective analysis of traditional external ventricular drains
Arm Type
Active Comparator
Arm Description
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
Intervention Type
Device
Intervention Name(s)
IRRAflow® Active Fluid Exchange System
Other Intervention Name(s)
IRRAflow® CNS System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional extraventricular drain
Intervention Description
The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
Intervention Type
Procedure
Intervention Name(s)
Non-contrast head CTs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Residual blood volume
Description
Residual blood volume on post bleed day 5
Time Frame
At day 5
Secondary Outcome Measure Information:
Title
Serious adverse events
Description
Number of serious adverse events
Time Frame
up to 48 hours post-procedure
Title
Hospital quality metrics
Description
Length of stay in the NSICU as a quality metrics
Time Frame
up to 48 hours post-procedure
Title
Length of stay in the NSICU
Description
Length of hospital stay in the as a quality metrics
Time Frame
up to 48 hours post-procedure
Title
Direct hospitalization costs
Description
Direct hospitalization costs
Time Frame
up to 48 hours post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher P Kellner, MD
Phone
212-241-2606
Email
christopher.kellner@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Trevor Hardigan, MD PhD
Phone
212-241-2606
Email
trevor.hardigan@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher P Kellner, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher P Kellner, MD
Phone
212-241-2606
Email
christopher.kellner@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Trevor Hardigan, MD PhD
Phone
212-241-2606
Email
trevor.hardigan@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Christopher P Kellner

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In order to minimize any privacy risks to the patients participating, IPD data will not be shared.

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Intraventricular Catheter System for IVH

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