Clinical trial NCT05113381: 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
Overall status: RECRUITING
Phase: NA
Conditions: Intraventricular Hemorrhage
Subarachnoid Hemorrhage
Keywords: interventricular hemorrhage
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of flushing interventions to address occlusions
timeFrame: study device implantation through study device removal
Secondary outcomes:
measure: Change of hemorrhage volume
timeFrame: Device implantation through to 90-Day follow-up
measure: Assessment of Glasgow Coma Score (GCS)
timeFrame: Device implantation through to 90-Day follow-up
measure: Assessment of Modified Rankin Score (mRS)
timeFrame: Device implantation through to 90-Day follow-up
measure: Assessment of National Institute of Health Stroke Scale (NIHSS)
timeFrame: Device implantation through to 90-Day follow-up
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Dayton
country: United States
facility: Wright State University/Premier Health
state: Ohio
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Department of Neurosurgery
state: Virginia
Study officials:
affiliation: University of Utah Health
name: Ramesh Grandhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Integra Life Sciences
name: Jason Marzuola, MSN
role: STUDY_DIRECTOR
References:
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.
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.
citation: Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.