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Catheter

CerebroFlo™ EVD Catheter for Intraventricular Hemorrhage

N/A
Recruiting
Led By Ramesh Grandhi, MD
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
Subjects known to have a bleeding diathesis.
Subjects with a scalp infection present.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up device implantation through to 90-day follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how often medical interventions to treat Flushing (redness and swelling) occur during the treatment of two types of hemorrhages.

Who is the study for?
This study is for adults over 18 who need an EVD Catheter for intraventricular hemorrhage treatment and can legally consent. It's not for those with uncorrectable bleeding disorders, catheter-related bleeding, scalp infections, pregnancy, or if the catheter was placed directly into a hematoma.
What is being tested?
The trial tests the CerebroFlo™ EVD Catheter's effectiveness in preventing blockages during treatment of brain bleeds due to hemorrhage. The main focus is on how often flushing interventions are needed to clear occlusions.
What are the potential side effects?
Potential side effects may include complications from catheter placement such as additional bleeding or infection at the insertion site. Specific side effects related to CerebroFlo™ itself will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had a CerebroFlo EVD Catheter placed after a brain hemorrhage without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes abnormal bleeding.
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I currently have a scalp infection.
Select...
I have a bleeding disorder that can't be corrected, caused by blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~device implantation through to 90-day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and device implantation through to 90-day follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of flushing interventions to address occlusions
Secondary study objectives
Assessment of Glasgow Coma Score (GCS)
Assessment of Modified Rankin Score (mRS)
Assessment of National Institute of Health Stroke Scale (NIHSS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraventricular Hemorrhage SubjectsExperimental Treatment1 Intervention
Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage

Find a Location

Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
108 Previous Clinical Trials
11,185 Total Patients Enrolled
1 Trials studying Subarachnoid Hemorrhage
250 Patients Enrolled for Subarachnoid Hemorrhage
Ramesh Grandhi, MDPrincipal InvestigatorUniversity of Utah Health
Jason Marzuola, MSNStudy DirectorIntegra Life Sciences
1 Previous Clinical Trials
500 Total Patients Enrolled

Media Library

Subarachnoid Hemorrhage Research Study Groups: Intraventricular Hemorrhage Subjects
Subarachnoid Hemorrhage Clinical Trial 2023: CerebroFlo™ EVD Catheter Highlights & Side Effects. Trial Name: NCT05113381 — N/A
~26 spots leftby Nov 2025
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