Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intraventricular Hemorrhage
- Sponsor
- Ohio State University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
- Status
- Recruiting
- Last Updated
- last year
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.
Investigators
Patrick Youssef
Clinical Assistant Professor of Neurological Surgery
Ohio State University
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
Outcomes
Primary Outcomes
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Time Frame: Immediately post-procedure
Secondary Outcomes
- Indwell time of EVD/Drainage and IRRAflow Catheter(Immediately post-procedure)
- Length of ICU stay(Baseline)
- Rate of shunt dependency(Immediately post-procedure)
- 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)
- Functional Status - at inclusion and 30 days(30 days post subject discharge)
- Rate of catheter-related infection(Immediately post-procedure)