Intraventricular Catheter System for IVH

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 14, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Intraventricular Hemorrhage (IVH)
Interventions
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."

DEVICE

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.

Trial Locations (1)

10128

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

IRRAS

INDUSTRY

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT05970549 - Intraventricular Catheter System for IVH | Biotech Hunter | Biotech Hunter