The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).
Potential study candidates will be screened for inclusion and exclusion criteria after informed consent has been provided by the Legally Acceptable Representative and/or the study candidate. Once enrolled in the study, data will be collected from those subjects with elevated intracranial pressure (ICP), interventricular hemorrhage, or hydrocephalic shunt infections as a result of the use of the EVD catheter. Pre-insertion and peri-removal CT scans and neurological assessment data will also be collected. Data will be collected for subjects beginning from the time of hospital admission through discharge and followed by the 30 Day and 90 Day Follow up Visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
The CerebroFlo™ EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
Loma Linda University Health
Loma Linda, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Number of flushing interventions to address occlusions
The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.
Time frame: study device implantation through study device removal
Change of hemorrhage volume
Change of hemorrhage volume as assessed on pre- and post-insertion of the CerebroFlo device as assessed on CT scan
Time frame: Device implantation through to 90-Day follow-up
Assessment of Glasgow Coma Score (GCS)
Assessment of Glasgow Coma Score (GCS) at Admission, Discharge, 30-Day and/or 90-Day timepoints The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points). Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language). It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.
Time frame: Device implantation through to 90-Day follow-up
Assessment of Modified Rankin Score (mRS)
Assessment of Modified Rankin Score (mRS) at Admission, Discharge, 30-Day and/or 90-Day timepoints The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. Lower scores correlate with less disability/dependence
Time frame: Device implantation through to 90-Day follow-up
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AdventHealth Orlando
Orlando, Florida, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Wright State University/Premier Health
Dayton, Ohio, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Virginia Commonwealth University Department of Neurosurgery
Richmond, Virginia, United States
Assessment of National Institute of Health Stroke Scale (NIHSS)
Assessment of National Institute of Health Stroke Scale (NIHSS) at Admission, Discharge, 30-Day and/or 90-Day timepoints NIH Stroke Scale/Score (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Time frame: Device implantation through to 90-Day follow-up