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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113381
• Other study ID #: C-CERFLO-001
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Integra LifeSciences Corporation
• Contact: Andrew Tummon
• Phone: 609-936-5490
• Email: andrew.tummon[@]integralife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intraventricular Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	study device implantation through study device removal
Secondary	Change of hemorrhage volume	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
Secondary	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.	Device implantation through to 90-Day follow-up
Secondary	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	Device implantation through to 90-Day follow-up
Secondary	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.	Device implantation through to 90-Day follow-up