Status:
RECRUITING
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
IRRAS
Conditions:
Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Acti...
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years of age
- Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
- Signed informed consent obtained by subject or Legally Authorized Representative
Exclusion Criteria:
- Subject has fixed and dilated pupils
- Pregnant women
- Presence of Moyamoya
- History or presence of clotting disorder.
- Platelet count less than 100,000, INR greater than 1.4
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05649904
Start Date
February 7 2023
End Date
January 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210