Study of the IRRAflow System for Clearing Brain Bleeding and Treating Intracranial Infections in Adults

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.

Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System