Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Christopher P Kellner
250 participants
Sep 25, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- GCS ≤ 5
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
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Interventions
The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.
Locations(1)
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NCT06649097