Intraventricular HemorrhageNCT05113381
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH)
A study testing CerebroFlo™ EVD Catheter in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Integra LifeSciences Corporation at 10 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraventricular Hemorrhage, Subarachnoid Hemorrhage
- What is being tested?
- CerebroFlo™ EVD Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Sep 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject and/or legally authorized representative has reviewed the Institutional Review Board (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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Wright State University/Premier Health
Dayton, Ohio, 45409
Loma Linda University Health
Loma Linda, California, 92350
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94304
Virginia Commonwealth University Department of Neurosurgery
Richmond, Virginia, 23298
University of Utah Health
Salt Lake City, Utah, 84123
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: 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).
Read the 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.
- Being tested
- CerebroFlo™ EVD Catheter
- Keywords
- interventricular hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerebroFlo™ EVD CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraventricular Hemorrhage Subjects | Experimental | Intervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage Receives: Device: CerebroFlo™ EVD Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: study device implantation through study device removal
Secondary outcomes (4)
Change of hemorrhage volume
Change of hemorrhage volume as assessed on pre- and post-insertion of the CerebroFlo device as assessed on CT scan
Measured: Device implantation through to 90-Day follow-up
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.
Measured: Device implantation through to 90-Day follow-up
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
Measured: Device implantation through to 90-Day follow-up
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.
Measured: Device implantation through to 90-Day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start15 Sep 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramesh Grandhi, MD, Principal investigator, University of Utah HealthJason Marzuola, MSN, Study director, Integra Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113381
- Sponsor's protocol ID
- C-CERFLO-001
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2021
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31669535Fargen 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.
PubMed 26517777Crites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter
- ClinicalTrials.gov ID
- NCT05113381
- Acronym / sponsor ID
- C-CERFLO-001
- Keywords
- interventricular hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraventricular Hemorrhage Subjects | Experimental | Device: CerebroFlo™ EVD CatheterIntervention: Cerebrospinal Fluid (CSF) reduction Extra Ventricular Drainage (EVD) catheters will be used for cerebrospinal fluid drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject and/or legally authorized representative has reviewed the Institutional Review Board (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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerebroFlo™ EVD CatheterThe 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. | Device | Intraventricular Hemorrhage Subjects |
Primary outcome
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.
4 secondary outcomes
Change of hemorrhage volume
Time frame: 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 Modified Rankin Score (mRS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 31669535Aten 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.
- Background: PubMed 26517777Fargen 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.
- BackgroundCrites L. Reducing Catheter-Related Complications with New Anti-thrombiogenic PICC. JAVA. 2015:20(4):256.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh Grandhi, MD principal investigator
University of Utah Health
Jason Marzuola, MSN study director
Integra Life Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CerebroFlo™ EVD Catheter in people with Intraventricular Hemorrhage and Subarachnoid Hemorrhage, run by Integra LifeSciences Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of flushing interventions to address occlusions (time frame: study device implantation through study device removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113381, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.