AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis (AFFECT)
Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma
About this trial
This is an interventional treatment trial for Intraventricular Hemorrhage
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
Sites / Locations
- The Ohio State University Wexner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
IRRAflow with Active Fluid Exchange System (IRRAflow)
External Ventricular Drainage (EVD)
Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.
Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.