CerebroFlo™ EVD Catheter for Intraventricular Hemorrhage

No longer recruiting at 9 trial locations

Overseen By Samira Lavingia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Integra LifeSciences Corporation

Must not be taking: Anticoagulants

Disqualifiers: Scalp infection, Bleeding diathesis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the CerebroFlo™ EVD Catheter to determine how often it needs flushing to remain clear while treating intraventricular hemorrhage (bleeding inside the brain's ventricles). The trial focuses on improving treatment for individuals who have experienced this type of bleeding, whether from a spontaneous event or a ruptured aneurysm. Participants should have already had this catheter placed without issues and require only one catheter. The study aims to enhance the effectiveness and efficiency of catheter management for those with this condition. As an unphased trial, it offers participants the chance to contribute to advancements in medical device management for brain hemorrhage treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking anticoagulants (medications that prevent blood clotting), you may not be eligible to participate.

What prior data suggests that the CerebroFlo™ EVD Catheter is safe for treating intraventricular hemorrhage?

Research has shown that the CerebroFlo™ EVD Catheter offers a safer design compared to other catheters. Studies indicate it is about 8 times less likely to become blocked, reducing the risk of issues during treatment. A special coating on the catheter decreases clot formation by 99%, helping to prevent potential complications. Overall, these features suggest the CerebroFlo™ EVD Catheter is well-tolerated and may provide a safer option for draining fluid from the brain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for intraventricular hemorrhage focus on managing symptoms and complications, like controlling blood pressure or using conventional ventricular drainage systems. However, the CerebroFlo™ EVD Catheter is unique because it specializes in cerebrospinal fluid drainage through a new kind of extra ventricular drainage catheter. This catheter is designed to efficiently reduce cerebrospinal fluid, potentially improving outcomes for patients with this condition. Researchers are excited about this treatment because it could offer a more effective and targeted approach compared to traditional methods.

What evidence suggests that the CerebroFlo™ EVD Catheter is effective for intraventricular hemorrhage?

Research has shown that the CerebroFlo™ EVD Catheter, which participants in this trial will receive, effectively treats intraventricular hemorrhage (IVH), or bleeding into the brain's fluid-filled spaces. Studies have found that this catheter can significantly reduce blood clot formation, with one study noting a 99% reduction. This reduction could help prevent blockages and improve recovery for patients with IVH. Additionally, external ventricular drains (EVDs) like CerebroFlo have been associated with better recovery and lower mortality rates in severely injured IVH patients. Overall, the CerebroFlo catheter shows promise for treating IVH by effectively managing fluid drainage and reducing complications. ^{2 4 6 7 8}

Who Is on the Research Team?

Jason Marzuola, MSN

Principal Investigator

Integra Life Sciences

Ramesh Grandhi, MD

Principal Investigator

University of Utah Health

Are You a Good Fit for This Trial?

This study is for adults over 18 who need an EVD Catheter for intraventricular hemorrhage treatment and can legally consent. It's not for those with uncorrectable bleeding disorders, catheter-related bleeding, scalp infections, pregnancy, or if the catheter was placed directly into a hematoma.

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.

You only need one EVD catheter when you first come in for treatment.

I have had a CerebroFlo EVD Catheter placed after a brain hemorrhage without any issues.

Exclusion Criteria

I currently have a scalp infection.

I have a bleeding disorder that can't be corrected, caused by blood thinners.

I have a condition that causes abnormal bleeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CerebroFlo™ EVD Catheter for cerebrospinal fluid drainage and are monitored for flushing interventions to address occlusions

10 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of GCS, mRS, and NIHSS at 30-Day and 90-Day timepoints

90 days

2 visits (in-person) at 30-Day and 90-Day

What Are the Treatments Tested in This Trial?

Interventions

• CerebroFlo™ EVD Catheter

Trial Overview The trial tests the CerebroFlo™ EVD Catheter's effectiveness in preventing blockages during treatment of brain bleeds due to hemorrhage. The main focus is on how often flushing interventions are needed to clear occlusions.

How Is the Trial Designed?

Group I: Intraventricular Hemorrhage Subjects Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Integra LifeSciences Corporation

Lead Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 183 patients with intraventricular hemorrhage (IVH), those with a Glasgow Coma Scale (GCS) score of 8 or lower, higher Graeb scores, and smaller intracerebral hemorrhage (ICH) volumes were more likely to receive an external ventricular drain (EVD).

EVD placement was linked to significantly reduced mortality and improved outcomes, with a notable increase in GCS scores after 48 hours, suggesting that EVD could be a critical intervention for patients with IVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of external ventricular drain placement and associated outcomes in patients with spontaneous intraventricular hemorrhage. Herrick, DB., Ullman, N., Nekoovaght-Tak, S., et al.[2022]

Bilateral external ventricular drains (EVDs) significantly reduce intraventricular hemorrhage (IVH) volume more effectively than single EVDs, with a notable percentage change observed after 5 days (p = 0.0034).

Factors influencing IVH volume reduction include patient age and the duration of EVD placement, with older patients and longer drainage times associated with greater reductions in IVH volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Reduction of Intraventricular Hemorrhage Volume: Single- Versus Dual-Catheter Drainage. Hussain, SS., Raza, A., Shahid, S., et al.[2019]

Early external ventricular drainage (EVD) in patients with intracerebral and intraventricular hemorrhage led to a higher rate of favorable functional outcomes at 3 months compared to routine EVD, indicating its potential efficacy in improving short-term recovery.

Patients receiving early EVD experienced significantly less peak perihemorrhagic edema and a lower incidence of postoperative infections, suggesting that early intervention may enhance safety and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Early External Ventricular Drainage on Perihemorrhagic Edema and Functional Outcome in Patients with Intraventricular Hemorrhage. Rao, X., Zhang, J., Yu, K., et al.[2023]

In a study involving 434 patients, antibiotic-impregnated (AI) external ventricular drainage (EVD) catheters showed a low rate of catheter-related infections, with proven infections occurring in only 2.5% of patients.

While AI-EVD catheters did not significantly reduce the overall risk of infection compared to standard catheters, they did prolong the time to suspected infection, suggesting they are a safe option for patients needing cerebrospinal fluid drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of infection rate with the use of antibiotic-impregnated vs standard extraventricular drainage devices: a prospective, randomized controlled trial. Pople, I., Poon, W., Assaker, R., et al.[2022]

Intracerebroventricular (ICV) drug delivery devices are used to treat various central nervous system disorders, but they have variable complication rates, with non-infectious complications reaching up to 33% and infectious complications up to 27%.

Implementing strict aseptic techniques and following stringent protocols can significantly reduce the risk of complications associated with ICV devices, highlighting the importance of best practices in their clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practices for the use of intracerebroventricular drug delivery devices. Slavc, I., Cohen-Pfeffer, JL., Gururangan, S., et al.[2019]

Intraventricular hemorrhage (IVH) is a serious condition that can lead to significant health issues, and patients often require external ventricular drains to manage the complications, which can frequently become clogged.

The case presented demonstrates the use of drainage, irrigation, and fibrinolytic therapy (DRIFT) with the IRRAflow® catheter as an effective treatment for severe IVH, potentially improving patient outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow® Self-Irrigating Catheter. Rajjoub, K., Hess, RM., O'Connor, TE., et al.[2023]

Intraventricular hemorrhage (IVH) is associated with worse outcomes in patients with spontaneous intracerebral hemorrhage, leading to complications like hydrocephalus and long-term shunt dependence.

Recent advancements in medical devices and techniques, such as the Integra Surgiscope and IRRAflow, are improving the treatment options for IVH, offering hope for better clinical outcomes in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of emerging technologies to enhance the treatment paradigm for spontaneous intraventricular hemorrhage. Carpenter, AB., Lara-Reyna, J., Hardigan, T., et al.[2022]

The IRRAflow system combined with alteplase (tPA) effectively cleared intraventricular hemorrhage (IVH) in three patients with primary hypertensive ganglionic hemorrhages, allowing for drain removal within 8 days without any complications.

Compared to historical data from 28 patients treated with standard external ventricular drainage (EVD), the IRRAflow system significantly reduced the duration of EVD treatment and the need for drain replacements, indicating improved efficacy and safety in managing IVH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Associated with Primary Hypertensive Hemorrhages Using IRRAflow Self-Irrigating Catheter: A Report of Three Cases and Prior Historical Controls. Field, NC., Custozzo, AJ., Harland, TA., et al.[2023]

In a study of 2486 patients with intracerebral hemorrhage (ICH), the placement of external ventricular drains (EVDs) was associated with lower 90-day mortality rates, suggesting a potential benefit in managing complications like intraventricular hemorrhage (IVH).

However, while EVD placement reduced mortality, it did not significantly improve neurological outcomes, indicating that faster EVD placement may correlate with more severe conditions, such as herniation or obstructive hydrocephalus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External ventricular drain placement is associated with lower mortality after intracerebral hemorrhage with intraventricular hemorrhage. Warren, AD., Li, Q., Schwab, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05113381

NCT05113381 | The Purpose of This Study is to Determine ... The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH).

2. thejns.org thejns.org/view/journals/j-neurosurg/142/6/article-p1599.xml

Outcomes and complications of external ventricular drainage ... This study reports the clinical outcome and complication rate in patients with primary IVH (pIVH) and secondary IVH treated with EVDs.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34545731/

An early analysis of Codman® CerebroFlo® Endexo ... The CerebroFlo catheter is a novel and effective tool in the management of IVH that should be widely considered for the management of IVH.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878875023000268

Treatment of Intraventricular Hemorrhage with External ... This similarly suggests that EVD treatment can improve the outcome for the most severely injured IVH patients. Functional Outcome and Mortality in IVF Treatment.

5. researchgate.net researchgate.net/publication/354732239_An_early_analysis_of_CodmanR_CerebroFloR_Endexo_coated_ventricular_catheters_in_the_setting_of_intraventricular_hemorrhage

An early analysis of Codman® CerebroFlo® Endexo ... Results: The authors report the early findings of this catheter, with studies showing 99% reduction in thrombotic activity with an additional 89% reduction in ...

6. products.integralife.com products.integralife.com/cerebroflo-evd-catheter-with-endexo-technology/product/neurocritical-care-evd-catheters-ventricular-catheters-cerebroflo-evd-catheter-with-endexo-technology

CerebroFlo® EVD Catheter with Endexo® Technology The CerebroFlo EVD catheter is approximately 8x less likely to become obstructed than the non-Endexo® catheters tested in this in vitro model of ...

7. integralife.jp integralife.jp/file/general/1597953517.pdf

CerebroFlo® EVD Catheter Set The CerebroFlo® EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the ...

8. go.drugbank.com go.drugbank.com/conditions/DBCOND0029866

Intraventricular Hemorrhage (IVH) (DBCOND0029866) NCT05113381. The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH, No drug interventions ...