AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Ohio State University
You may qualify if…
- ✓ 1. Age ≥18 years of age
- ✓ 2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- ✓ 3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- ✓ 4. Signed informed consent obtained by subject or Legally Authorized Representative
You may not qualify if…
- ✕ 1. Subject has fixed and dilated pupils
- ✕ 2. Pregnant women
- ✕ 3. Presence of Moyamoya
- ✕ 4. History or presence of clotting disorder.
- ✕ 5. Platelet count less than 100,000, INR greater than 1.4
Where it's recruiting
Columbus
Source: ClinicalTrials.gov · NCT05649904 · last updated 2025-04-01