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

Primary Purpose

Intraventricular Hemorrhage, Subarachnoid Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CerebroFlo™ EVD Catheter
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage focused on measuring interventricular hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford UniversityRecruiting
  • University of Colorado Anschutz Medical CampusRecruiting
  • AdventHealth Orlando
  • Our Lady of the Lake Regional Medical CenterRecruiting
  • Wright State University/Premier HealthRecruiting
  • University of Texas Health Science CenterRecruiting
  • University of Utah HealthRecruiting
  • Virginia Commonwealth University Department of NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraventricular Hemorrhage Subjects

Arm Description

Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage

Outcomes

Primary Outcome Measures

Number of flushing interventions to address occlusions
The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.

Secondary Outcome Measures

Change of hemorrhage volume
Change of hemorrhage volume as assessed on pre- and post-insertion of the CerebroFlo device as assessed on CT scan
Assessment of Glasgow Coma Score (GCS)
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.
Assessment of Modified Rankin Score (mRS)
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
Assessment of National Institute of Health Stroke Scale (NIHSS)
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.

Full Information

First Posted
July 27, 2021
Last Updated
January 26, 2023
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05113381
Brief Title
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
Official Title
A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage, Subarachnoid Hemorrhage
Keywords
interventricular hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraventricular Hemorrhage Subjects
Arm Type
Experimental
Arm Description
Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage
Intervention Type
Device
Intervention Name(s)
CerebroFlo™ EVD Catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of flushing interventions to address occlusions
Description
The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.
Time Frame
study device implantation through study device removal
Secondary Outcome Measure Information:
Title
Change of hemorrhage volume
Description
Change of hemorrhage volume as assessed on pre- and post-insertion of the CerebroFlo device as assessed on CT scan
Time Frame
Device implantation through to 90-Day follow-up
Title
Assessment of Glasgow Coma Score (GCS)
Description
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.
Time Frame
Device implantation through to 90-Day follow-up
Title
Assessment of Modified Rankin Score (mRS)
Description
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
Time Frame
Device implantation through to 90-Day follow-up
Title
Assessment of National Institute of Health Stroke Scale (NIHSS)
Description
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.
Time Frame
Device implantation through to 90-Day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Tummon
Phone
609-936-5490
Email
andrew.tummon@integralife.com
First Name & Middle Initial & Last Name or Official Title & Degree
Crystal George, MS
Phone
469-968-4132
Email
crystal.george@integralife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Grandhi, MD
Organizational Affiliation
University of Utah Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Marzuola, MSN
Organizational Affiliation
Integra Life Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Alexander
Email
sashalex@stanford.edu
First Name & Middle Initial & Last Name & Degree
Anthony Bet
Email
abet0915@stanford.edu
First Name & Middle Initial & Last Name & Degree
Lawrence Shuer, MD
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Maitlen
Email
jennifer.maitlen@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Luis Cava, MD
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Toler, RN
Phone
225-765-7733
Email
Rebecca.Toler@fmolhs.org
First Name & Middle Initial & Last Name & Degree
Allen Joseph, MD
Facility Name
Wright State University/Premier Health
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Burnside
Email
baburnside@premierhealth.com
First Name & Middle Initial & Last Name & Degree
Daniel Gaudin, MD
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Rhodes
Email
rhodesc1@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Ali Seifi, MD
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Douglas, BS, CCRC
Phone
801-791-8741
Email
Rachel.Douglas@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Sarah Menacho, MD
Facility Name
Virginia Commonwealth University Department of Neurosurgery
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mally Jones
Email
mallory.jones@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Brian Cameron, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31669535
Citation
Aten Q, Killeffer J, Seaver C, Reier L. Causes, Complications, and Costs Associated with External Ventricular Drainage Catheter Obstruction. World Neurosurg. 2020 Feb;134:501-506. doi: 10.1016/j.wneu.2019.10.105. Epub 2019 Oct 25.
Results Reference
background
PubMed Identifier
26517777
Citation
Fargen KM, Hoh BL, Neal D, O'connor T, Rivera-Zengotita M, Murad GJ. The burden and risk factors of ventriculostomy occlusion in a high-volume cerebrovascular practice: results of an ongoing prospective database. J Neurosurg. 2016 Jun;124(6):1805-12. doi: 10.3171/2015.5.JNS15299. Epub 2015 Oct 30.
Results Reference
background
Citation
Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.
Results Reference
background

Learn more about this trial

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

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