Actively Recruiting
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Led by Christopher P Kellner · Updated on 2025-10-28
250
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
C
Christopher P Kellner
Lead Sponsor
I
IRRAS
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the IRRAflow Active Fluid Exchange System in patients with intracranial hemorrhage, ventriculitis, or intracranial abscess. This multi-center, prospective cohort, controlled phase 4 post-market registry study compares the IRRAflow device to standard external ventricular drains, focusing on its effectiveness and radiographic outcomes. The study aims to provide insights into treatment options for these serious brain conditions. The IRRAflow system combines automated irrigation, controlled drainage, and intracranial pressure monitoring in one device. All participants will receive treatment with the IRRAflow device, along with additional supportive care and medical treatments as determined by their doctors, including neurointensive care and procedures to address sources of bleeding such as vascular anomalies or aneurysms. The study will follow patients starting within 72 hours of their last known well time. Participants will be monitored through imaging scans like CT or MRI to assess residual blood volume by day 5 after the procedure and will have their functional outcomes measured at 6 months. Other evaluations include blood clearance rate, hospital and intensive care unit length of stay, costs, and need for shunt placement. The total participation time includes follow-up to six months, with continuous monitoring of safety and clinical outcomes throughout the study.
CONDITIONS
Brief Title
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Intracranial hemorrhage confirmed by head CT or MRI scan
- Active fluid exchange treatment recommended by treating physician
- Signed informed consent by patient or legal representative
- Enrollment and treatment scheduled within 72 hours of last known well time
You will not qualify if you...
- Glasgow Coma Scale score of 5 or less
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 72 hours before treatment
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 7 days post procedure
Participants receive treatment with the IRRAflow device, which provides automated irrigation, controlled drainage, and intracranial pressure monitoring for intracranial hemorrhage.
Daily visits during hospitalization up to discharge or 7 days post procedure
Duration - Up to 6 months
Participants are monitored for outcomes including residual blood volume, neurological function, and hospitalization metrics after treatment with the IRRAflow device.
Follow-up visits conducted at discharge and at 6 months
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sukaina Davdani
S
Sydney Edwards
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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