Study of IRRAflow® System for Intraventricular Hemorrhage

This study is looking at a new way to treat Intraventricular Hemorrhage (IVH), which is bleeding inside the brain's fluid-filled spaces. It compares a device called the IRRAflow® Active Fluid Exchange System to the standard treatment, a traditional extraventricular drain. The IRRAflow® system helps drain fluid and reduce pressure in the brain. The study wants to see if the IRRAflow® system is safe and works better than current methods. You might be able to join if you are 18 or older, have IVH confirmed by a scan, need fluid drainage, and can start treatment within 72 hours of the bleeding. The main goal is to see how much blood remains in the brain after 5 days.

Study design
This study will enroll 17 participants in the IRRAflow® arm, and will also look back at data from 60 patients who received traditional treatment. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would have non-contrast head CT scans at least every 48 hours to check the treatment's effectiveness. The IRRAflow® catheter would be inserted by neurosurgical staff.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, residual blood volume, is measured at day 5 after treatment.

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NCT05970549

Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage

Recruiting
NAAges 18+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~17 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:IRRAflow® Active Fluid Exchange SystemTraditional extraventricular drainNon-contrast head CTs

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
Measured over At day 5
Intraventricular Hemorrhage (IVH)
1 sites across 1 states
New York1
  • Christopher P Kellner, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

Age \>=18 years of age
Intraventricular hemorrhage documented on head CT or MRI scan
Need of cerebrospinal fluid drainage
Indication for active treatment evaluated by the treating physicians
Signed informed consent obtained by patient or Legal Authorized Representative
Treatment possible within 72 hours of ictus

Exclusion

Patient has fixed and dilated pupils
Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
  • Residual blood volumeAt day 5

    Residual blood volume on post bleed day 5