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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Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Christopher Kellner · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Nicholas Brandmeir · PRINCIPAL_INVESTIGATOR · West Virginia University
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 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