Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System

What this Trial Is About

Researchers are evaluating whether active irrigation using the IRRAflow device combined with tissue plasminogen activator (tPA) can speed up the clearance of blood from intracerebral and intraventricular hemorrhages compared to standard passive drainage with tPA. The study aims to assess if this method improves neurological outcomes, measured by scales like the Glasgow Coma Scale and modified Rankin Scale. This is an international, prospective, randomized, controlled, multicenter study sponsored by IRRAS. Participants are assigned to one of three groups: IRRAflow with manual tPA administration followed by active fluid exchange, IRRAflow with continuous tPA infusion combined with active fluid exchange, or standard external ventricular drainage (EVD) with manual tPA administration. IRRAflow is a device that uses a dual-lumen catheter to actively exchange pathological fluids with neutral fluids, while EVD is a traditional device for relieving elevated intracranial pressure. Treatments are delivered within 72 hours of the hemorrhage onset and involve tPA dosing of 2.0 mg per day for three days if needed. During the study, participants are monitored through head CT scans to evaluate blood removal radiographically and assessed using neurological outcome scales up to 30 days after hospital discharge. Researchers also track procedural and technical success and monitor safety outcomes such as catheter placement issues, infections, and bleeding events. The total participation timeline includes intra-procedure measurement and follow-up evaluations post-discharge.

Active Removal of IntraCerebral Hematoma Via Active Irrigation