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Intraventricular Hemorrhage (IVH)DeviceProcedure

What this study is

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.

What's being tested

  • IRRAflow® Active Fluid Exchange System

    Intervention · DEVICE

    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

    Intervention · DEVICE

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

  • Non-contrast head CTs

    Intervention · PROCEDURE

    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.

Study details

Official title
DIVE: Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
Sponsor
Icahn School of Medicine at Mount Sinai
Conditions
Intraventricular Hemorrhage (IVH)
Enrolling
17 people
Starts
2022-06-14
Est. completion
2026-12-31
Design
Open-label, non-randomized, single group
Record
View on ClinicalTrials.gov ↗