The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)

Completed · Not applicable

Conditions studied: Intraventricular Hemorrhage, Subarachnoid Hemorrhage

In brief

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).

Key facts

Study ID

NCT05113381

Run by

Integra LifeSciences Corporation

People needed

105

Starts

2021-09-15

Expected to finish

2025-07-31

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject and/or legally authorized representative has reviewed the Institutional Review Board (IRB)-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
• Subject is ≥ 18 years of age at the time of consent.
• Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication.
• Subjects who require only one EVD Catheter at initial admission

You may not qualify if…

• Subjects with a scalp infection present.
• Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.
• Subjects known to have a bleeding diathesis.
• Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
• Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan.
• Subject is pregnant

Where it is running

• 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

Full record on ClinicalTrials.gov

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