The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)
NCT ID: NCT05113381
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
105 participants
INTERVENTIONAL
2021-09-15
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraventricular Hemorrhage Subjects
Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage
CerebroFlo™ EVD Catheter
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.
Interventions
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CerebroFlo™ EVD Catheter
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.
Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥ 18 years of age at the time of consent.
3. Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication.
4. Subjects who require only one EVD Catheter at initial admission
Exclusion Criteria
2. Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.
3. Subjects known to have a bleeding diathesis.
4. Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
5. Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan.
6. Subject is pregnant
18 Years
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Ramesh Grandhi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah Health
Jason Marzuola, MSN
Role: STUDY_DIRECTOR
Integra Life Sciences
Locations
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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
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
Countries
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References
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Aten Q, Killeffer J, Seaver C, Reier L. Causes, Complications, and Costs Associated with External Ventricular Drainage Catheter Obstruction. World Neurosurg. 2020 Feb;134:501-506. doi: 10.1016/j.wneu.2019.10.105. Epub 2019 Oct 25.
Fargen KM, Hoh BL, Neal D, O'connor T, Rivera-Zengotita M, Murad GJ. The burden and risk factors of ventriculostomy occlusion in a high-volume cerebrovascular practice: results of an ongoing prospective database. J Neurosurg. 2016 Jun;124(6):1805-12. doi: 10.3171/2015.5.JNS15299. Epub 2015 Oct 30.
Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.
Other Identifiers
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C-CERFLO-001
Identifier Type: -
Identifier Source: org_study_id
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