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

Christopher P Kellner

Status: Enrolling

Conditions: Intracranial Hemorrhage; Ventriculitis; Intracranial Abscess

Treatments: Device: IRRAflow® CNS (Active Fluid Exchange) System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06649097

STUDY-24-01230

Details and patient eligibility

About

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.

Full description

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.).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

IRRAflow device

Description:

All patients enrolled into the study will undergo treatment with the IRRAflow device

Treatment:

Device: IRRAflow® CNS (Active Fluid Exchange) System