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

January 16, 2024 updated by: Integra LifeSciences Corporation

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Potential study candidates will be screened for inclusion and exclusion criteria after informed consent has been provided by the Legally Acceptable Representative and/or the study candidate.

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.

Study Type

Interventional

Enrollment (Estimated)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Not yet recruiting
        • Loma Linda University Health
        • Principal Investigator:
          • Warren Boling, MD
        • Contact:
      • Palo Alto, California, United States, 94304
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Luis Cava, MD
    • Florida
      • Orlando, Florida, United States, 32803
        • Active, not recruiting
        • AdventHealth Orlando
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Allen Joseph, MD
    • New York
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Wright State University/Premier Health
        • Contact:
        • Principal Investigator:
          • Daniel Gaudin, MD
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84123
        • Recruiting
        • University of Utah Health
        • Contact:
        • Principal Investigator:
          • Sarah Menacho, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Department of Neurosurgery
        • Contact:
        • Principal Investigator:
          • Brian Cameron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraventricular Hemorrhage Subjects
Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of flushing interventions to address occlusions
Time Frame: study device implantation through study device removal
The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.
study device implantation through study device removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of hemorrhage volume
Time Frame: Device implantation through to 90-Day follow-up
Change of hemorrhage volume as assessed on pre- and post-insertion of the CerebroFlo device as assessed on CT scan
Device implantation through to 90-Day follow-up
Assessment of Glasgow Coma Score (GCS)
Time Frame: Device implantation through to 90-Day follow-up

Assessment of Glasgow Coma Score (GCS) at Admission, Discharge, 30-Day and/or 90-Day timepoints

The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).

Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).

It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness.
Device implantation through to 90-Day follow-up
Assessment of Modified Rankin Score (mRS)
Time Frame: Device implantation through to 90-Day follow-up

Assessment of Modified Rankin Score (mRS) at Admission, Discharge, 30-Day and/or 90-Day timepoints

The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. Lower scores correlate with less disability/dependence
Device implantation through to 90-Day follow-up
Assessment of National Institute of Health Stroke Scale (NIHSS)
Time Frame: Device implantation through to 90-Day follow-up

Assessment of National Institute of Health Stroke Scale (NIHSS) at Admission, Discharge, 30-Day and/or 90-Day timepoints

NIH Stroke Scale/Score (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items.
Device implantation through to 90-Day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: Ramesh Grandhi, MD, University of Utah Health
  • Study Director: Jason Marzuola, MSN, Integra Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-CERFLO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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