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Recruiting NCT06649097
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Trial Parameters
Condition Intracranial Hemorrhage
Sponsor Christopher P Kellner
Study Type OBSERVATIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-25
Completion 2031-01
All Conditions
Interventions
IRRAflow® CNS (Active Fluid Exchange) System
Brief 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 Criteria
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