IRRAflow System for Intracranial Blood Products

This study is looking at how well the IRRAflow® Active Fluid Exchange System works compared to standard treatments for clearing blood from the brain after an intracranial hemorrhage (bleeding in the brain), or for treating brain infections like ventriculitis or intracranial abscess. The IRRAflow system helps by automatically irrigating (washing), draining, and monitoring pressure inside the brain. You might be able to join if you are at least 18 years old, have bleeding in your brain confirmed by a scan, and your doctor thinks this system could help you. The study will look at how much blood remains in your brain after 5 days and your recovery at 6 months. The current status of this study is unclear, and it plans to enroll 250 participants.

Study design
This is an observational study comparing the IRRAflow system to standard care, involving 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your recovery will be assessed at 6 months after the study begins.

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NCT06649097

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

Recruiting
Not specifiedAges 18+Observational
Christopher P Kellner
~250 participants
Updated 2025-10-28 on ClinicalTrials.gov
What's tested:IRRAflow® CNS (Active Fluid Exchange) System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Residual blood volume by post bleed day 5
Measured over Post-procedure day 5
+1 more outcome measured
Intracranial Hemorrhage
Ventriculitis
Intracranial Abscess
1 sites across 1 states
New York1
  • Christopher Kellner · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Nicholas Brandmeir · PRINCIPAL_INVESTIGATOR · West Virginia University

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Eligibility criteria

Inclusion

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

GCS ≤ 5
Pregnancy
Fixed and dilated pupil
Life-threatening medical condition
  • Residual blood volume by post bleed day 5Post-procedure day 5

    The residual blood volume at day 5 will be calculated to determine the efficacy of the IRRAflow system compared to other external ventricular drains (EVDs)

  • Utility weighted modified Rankin ScoreEnd of study, at 6 months

    Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. Scores range from 0 to 6, with 0 indicating no disability and 6 indicating death