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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up device implantation through to 90-day follow-up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ device implantation through to 90-day follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of flushing interventions to address occlusions

Secondary outcome measures

Assessment of Glasgow Coma Score (GCS)

Assessment of Modified Rankin Score (mRS)

Assessment of National Institute of Health Stroke Scale (NIHSS)

+1 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor

84 Previous Clinical Trials

9,380 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available participation slots for this research endeavor?

"Affirmative. The clinicaltrials.gov registry shows that this particular medical trial, which was first posted on September 15th 2021, is seeking participants for a study involving 109 individuals from 7 different sites."

Answered by AI

What is the current population of participants in this trial?

"For this research to be successful, 109 qualified participants are required. Prospective patients can enrol in the trial from clinical sites like University of Utah Health (Salt Lake City) and Stanford University (Palo Alto)."

Answered by AI

How many venues are presently hosting this investigation?

"This medical trial is based out of University of Utah Health in Salt Lake City, Stanford University in Palo Alto and Our Lady of the Lake Regional Medical Center located in Baton Rouge. Additionally, there are 7 other locations associated with this study's operations."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

The Burden and Risk Factors of Ventriculostomy Occlusion in a High-volume Cerebrovascular Practice: Results of an Ongoing Prospective Database

Fargen, Kyle M., Brian L. Hoh, Dan Neal, Timothy O’connor, Marie Rivera-Zengotita, and Gregory J. A. Murad. 2016. “The Burden and Risk Factors of Ventriculostomy Occlusion in a High-volume Cerebrovascular Practice: Results of an Ongoing Prospective Database”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2015.5.jns15299.

World NeurosurgeryJournal

Causes, Complications, and Costs Associated with External Ventricular Drainage Catheter Obstruction

Aten, Quentin, James Killeffer, Chad Seaver, and Louis Reier. 2020. “Causes, Complications, and Costs Associated with External Ventricular Drainage Catheter Obstruction”. World Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2019.10.105.

clinicaltrials.govStudy

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

2021. "The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113381.

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