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

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

The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.

The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - [Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)], intracranial abscess, and ventriculitis.

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).

Inclusion criteria:

• Age >=18 years of age
• Intracranial hemorrhage documented on head CT or MRI scan.
• Indication for active fluid exchange evaluated by treating physician.
• Signed informed consent obtained by patient or Legal Authorized Representative
• Scheduled enrollment and treatment within 72 hours of last known well (LKW)

Exclusion criteria:

• GCS ≤ 5
• Pregnancy
• Fixed and dilated pupil
• Life-threatening medical condition