Treatment of Brain Bleeding and Infection Using Active Fluid Exchange Compared to Standard Drainage

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new device called the IRRAflow Active Fluid Exchange System compared to the standard External Ventricular Drain EVD in patients with brain bleeding and infections. This study focuses on conditions such as intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis. The goal is to see if the IRRAflow device can better remove cerebrospinal fluid, blood, and harmful bacteria from specific brain spaces. Participants will be randomly assigned to receive either the IRRAflow device or the EVD device. Both devices are used to monitor and reduce intracranial pressure by draining excess fluid from the brain. The IRRAflow system includes an irrigation feature to help keep the drainage catheter clear by using programmed pulses of fluid, while the EVD device represents the current standard care method. After the procedure, participants will be followed for one month to compare outcomes between the two groups. During the study, participants will undergo various assessments including head CT scans to measure clearance of blood or bacterial mass, monitoring for catheter-related infections, tracking the length of stay in intensive care, and evaluating functional status at the start and 30 days after discharge. Researchers will also monitor rates of revision procedures, shunt dependency, and mortality during and after treatment. The study aims to provide detailed information about how these devices perform in managing intracranial bleeding and infections over a one-month period.

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis