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Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Start Date
February 7, 2023
Primary Completion Date
January 1, 2026
Completion Date
January 1, 2026
Last Updated
April 1, 2025
240
ESTIMATED participants
IRRAflow with Active Fluid Exchange System
DEVICE
External Ventricular Drain
DEVICE
Lead Sponsor
Ohio State University
Collaborators
NCT06163547
NCT05374681
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07205263