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.

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NCT05649904

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

Recruiting
NAAges 18+InterventionalTreatment
Ohio State University
~240 participants
Updated 2025-04-01 on ClinicalTrials.gov
What's tested:IRRAflow with Active Fluid Exchange SystemExternal Ventricular Drain

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Measured over Immediately post-procedure
Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Subdural Hematoma
Ventriculitis
1 sites across 1 states
Ohio1
  • Patrick Youssef, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

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  • Rate of revision procedures for the IRRAflow and EVD/Drainage cathetersImmediately post-procedure