Assessing the effectiveness of the CerebroFlo™ EVD Catheter for treating intraventricular hemorrhage

A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter

This study is testing if the CerebroFlo™ EVD Catheter can effectively treat patients with intraventricular hemorrhage by looking at how often the catheter gets blocked and how patients recover over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 109 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Integra LifeSciences Corporation (industry)
• Locations: 11 sites (Loma Linda, California and 10 other locations)
• Trial ID: NCT05113381 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of the CerebroFlo™ EVD Catheter in treating patients with intraventricular hemorrhage (IVH) by monitoring the occurrence of flushing interventions to address catheter occlusions. Eligible participants will be screened based on specific inclusion and exclusion criteria, and data will be collected from hospital admission through discharge, including follow-up visits at 30 and 90 days. The study will involve pre-insertion and peri-removal CT scans, as well as neurological assessments to gather comprehensive data on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with intraventricular hemorrhage who require the placement of a single CerebroFlo™ EVD Catheter.

Not a fit: Patients with scalp infections, uncorrectable coagulopathy, or those with a bleeding diathesis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes for patients suffering from intraventricular hemorrhage by enhancing catheter management and reducing complications.

How similar studies have performed: Other studies have shown promise in catheter management for IVH, but the specific use of the CerebroFlo™ EVD Catheter in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Subject and/or legally authorized representative has reviewed the 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.
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:

1. Subjects with a scalp infection present.
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

Where this trial is running

Loma Linda, California and 10 other locations

• Loma Linda University Health — Loma Linda, California, United States (RECRUITING)
• Stanford University — Palo Alto, California, United States (RECRUITING)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
• AdventHealth Orlando — Orlando, Florida, United States (COMPLETED)
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States (COMPLETED)
• Icahn School of Medicine at Mt. Sinai — New York, New York, United States (RECRUITING)
• Wright State University/Premier Health — Dayton, Ohio, United States (RECRUITING)
• Medical City Plano — Plano, Texas, United States (WITHDRAWN)
• University of Texas Health Science Center — San Antonio, Texas, United States (RECRUITING)
• University of Utah Health — Salt Lake City, Utah, United States (RECRUITING)
• Virginia Commonwealth University Department of Neurosurgery — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Ramesh Grandhi, MD — University of Utah Health
• Study coordinator: Andrew Tummon

Conditions: Intraventricular Hemorrhage, Subarachnoid Hemorrhage, interventricular hemorrhage