AFFECT Study for Brain Bleeding and Infection
This study, called AFFECT, is for people who have bleeding in or around the brain (intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma) or a brain infection (ventriculitis). The goal is to see if a device called IRRAflow with Active Fluid Exchange System is better and safer than the standard External Ventricular Drain (EVD) for draining fluid, blood, and bacteria from the brain. You would be randomly assigned to receive either the IRRAflow device or the EVD device. Researchers will then compare how well each device works and how safe it is. This study is currently unclear on its recruitment status and aims to enroll 240 participants aged 18 and older who need brain drainage.
- Study design
- This is an interventional study where participants are randomly assigned to one of two treatment groups: IRRAflow or External Ventricular Drain (EVD). The study plans to enroll 240 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one month after the procedure to compare outcomes between the groups.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Patrick Youssef, MD · PRINCIPAL_INVESTIGATOR · Ohio State University
Who to contact
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What this trial measures
- Rate of revision procedures for the IRRAflow and EVD/Drainage cathetersImmediately post-procedure