CerebroFlo™ EVD Catheter for Intraventricular Hemorrhage

Recruiting at 7 trial locations

Overseen By Crystal George, MS

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

109 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the CerebroFlo™ EVD Catheter treatment for intraventricular hemorrhage?

The CerebroFlo™ EVD Catheter is part of a group of new technologies that are advancing the treatment of intraventricular hemorrhage (bleeding in the brain's ventricles), which is a serious condition. While specific data on CerebroFlo™ is not detailed, similar devices like external ventricular drains (EVDs) have been associated with lower mortality in patients with this condition, suggesting potential benefits. ^{1 2 3 4 5}

Is the CerebroFlo™ EVD Catheter safe for use in humans?

The CerebroFlo™ EVD Catheter is part of a group of devices used to treat brain conditions, and while specific safety data for CerebroFlo™ isn't detailed, similar devices have shown variable complication rates, with some reporting up to 33% for non-infectious and 27% for infectious issues. Using strict cleanliness and careful procedures can help reduce these risks. ^{3 4 5 6 7}

How is the CerebroFlo™ EVD Catheter treatment different from other treatments for intraventricular hemorrhage?

The CerebroFlo™ EVD Catheter is a novel catheter technology designed to improve the treatment of intraventricular hemorrhage by providing more efficient drainage of cerebrospinal fluid and blood from the brain's ventricles, potentially reducing complications like hydrocephalus and ventriculitis. Unlike standard external ventricular drainage systems, it may offer advancements in catheter design that enhance its effectiveness and reliability. ^{3 4 5 8 9}

Research Team

Ramesh Grandhi, MD

Principal Investigator

University of Utah Health

Jason Marzuola, MSN

Principal Investigator

Integra Life Sciences

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

External ventricular drain placement is associated with lower mortality after intracerebral hemorrhage with intraventricular hemorrhage. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Determinants of external ventricular drain placement and associated outcomes in patients with spontaneous intraventricular hemorrhage. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Use of emerging technologies to enhance the treatment paradigm for spontaneous intraventricular hemorrhage. [2022]

4. United States 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. [2023]

5. United States 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Postoperative Reduction of Intraventricular Hemorrhage Volume: Single- Versus Dual-Catheter Drainage. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Best practices for the use of intracerebroventricular drug delivery devices. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Early External Ventricular Drainage on Perihemorrhagic Edema and Functional Outcome in Patients with Intraventricular Hemorrhage. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow® Self-Irrigating Catheter. [2023]