Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ohio State University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IRRAflow with Active Fluid Exchange System (IRRAflow)
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.
Intervention: IRRAflow with Active Fluid Exchange System (Device)
External Ventricular Drainage (EVD)
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.
Intervention: External Ventricular Drain (Device)
Outcomes
Primary Outcomes
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Time Frame: Immediately post-procedure
Secondary Outcomes
- Rate of shunt dependency(Immediately post-procedure)
- Functional Status - at inclusion and 30 days(30 days post subject discharge)
- Indwell time of EVD/Drainage and IRRAflow Catheter(Immediately post-procedure)
- Length of ICU stay(Baseline)
- Time to clearance of blood or bacterial mass as measured by head CT scan(Immediately post-procedure)
- Mortality rates - intraprocedural and at 30 days(30 days post subject discharge)
- Rate of catheter-related infection(Immediately post-procedure)
Investigators
Patrick Youssef
Clinical Assistant Professor of Neurological Surgery
Ohio State University