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

Recruitingn/aAges 18 Years - anyAllChristopher P Kellner
NCT06649097 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • IRRAflow® CNS (Active Fluid Exchange) System
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Where

1 site
Icahn School of Medicine at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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