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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05113381
Other study ID # C-CERFLO-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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