Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Conditions

• Intraventricular Hemorrhage (IVH)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IRRAflow® Active Fluid Exchange System — 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 — DEVICE
  The retrospective analysis will be performed on the last 60 traditional external ventricular drains.
• Non-contrast head CTs — 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

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.

Key Dates

Start date

Jun 14, 2022

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

17 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.
• Active Comparator: Retrospective analysis of traditional external ventricular drains
  The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Primary Outcome Measure

Residual blood volume [ Time Frame: At day 5 ]

Central Contacts

• Emily Svendsen
  (212) 241-3238
  [email protected]
• Sydney Edwards
  (212) 241-2524
  [email protected]

Locations (1)

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