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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Deployment of Irrigating Intraventricular Catheter System for Intraventricular Hemorrhage
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christopher P Kellner, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Residual blood volumeAt day 5
Residual blood volume on post bleed day 5