Actively Recruiting
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Led by Ohio State University · Updated on 2025-04-01
240
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
I
IRRAS
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD). Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.
CONDITIONS
Official Title
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Need for drainage due to intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma, or ventriculitis
- Indication for active treatment of the above conditions as evaluated by treating physician
- Signed informed consent by the subject or legally authorized representative
You will not qualify if you...
- Fixed and dilated pupils
- Pregnant women
- Presence of Moyamoya disease
- History or presence of clotting disorders
- Platelet count below 100,000 or INR greater than 1.4
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
E
Edouard Beliaire
CONTACT
P
Patrick Youssef, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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