IRRAflow® Catheter System for Intraventricular Hemorrhage

(DIVE Trial)

Overseen by Christopher Kellner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Fixed pupils, Pregnant, Nursing

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a special tube called the IRRAflow® System to help drain fluid from the brain and reduce pressure. It targets patients with severe brain bleeding conditions. The system works by washing out blood and continuously checking brain pressure to prevent complications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the IRRAflow® Catheter System safe for use in humans?

The IRRAflow® Catheter System has been used in cases of intraventricular hemorrhage and cerebral ventriculitis, showing marked improvement in patients without specific safety concerns reported. It appears to be a promising tool for treating infectious and hemorrhagic brain conditions in intensive care settings. ^{1 2 3 4 5}

How does the IRRAflow® treatment differ from other treatments for intraventricular hemorrhage?

The IRRAflow® treatment is unique because it uses a self-irrigating catheter system that continuously flushes and drains the brain's ventricles, helping to remove blood clots and reduce pressure without frequent manual intervention, unlike traditional external ventricular drains that often require multiple exchanges. ^{1 3 4 6 7}

Research Team

Christopher Kellner, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for adults over 18 with a type of stroke that causes bleeding inside the brain's ventricles and requires fluid drainage. They must be able to start treatment within 72 hours of their stroke. Pregnant or nursing women, or those with fixed and dilated pupils, cannot participate.

Inclusion Criteria

My doctor has confirmed I need active treatment.

I am 18 years old or older.

I need a procedure to drain fluid from my brain.

Exclusion Criteria

I am not pregnant or nursing.

My pupils are fixed and do not respond to light.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the IRRAflow® System catheters for intracranial fluid drainage to reduce intracranial pressure

5 days

Daily monitoring in NSICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including residual blood volume and serious adverse events

up to 48 hours post-procedure

In-hospital monitoring

Retrospective Analysis

Retrospective analysis of traditional external ventricular drains

Treatment Details

Interventions

• IRRAflow® Active Fluid Exchange System (Procedure)
• Traditional extraventricular drain (Procedure)

Trial Overview The study compares the IRRAflow® Active Fluid Exchange System, which is FDA approved, to traditional drains in managing intracranial pressure after an intraventricular hemorrhage. Participants will also undergo non-contrast head CT scans as part of the evaluation.

Participant Groups

Group I: IRRAflow with Active Fluid Exchange arm Experimental Treatment 2 Interventions

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria.

Group II: Retrospective analysis of traditional external ventricular drains Active Control 1 Intervention

The retrospective analysis will be performed on the last 60 traditional external ventricular drains.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

IRRAS

Industry Sponsor

Trials

5

Recruited

730+

Findings from Research

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 42 patients with advanced heart failure, the INCOR LVAD demonstrated effective support with 1-year and 2-year survival rates of 74% and 60%, respectively.

Notably, there were no reported cases of pump thrombosis or gastrointestinal bleeding, highlighting the safety profile of the INCOR LVAD in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low incidence of gastrointestinal bleeding and pump thrombosis in patients receiving the INCOR LVAD system in the long-term follow-up. Iacovoni, A., Centofanti, P., Attisani, M., et al.[2017]

The IRRAflow® system, used for continuous irrigation and drainage of the cerebral ventricles, showed marked improvement in three patients with cerebral ventriculitis, indicating its efficacy in managing this life-threatening condition.

This system may also be beneficial for treating other brain injuries, such as intraventricular hemorrhage and intracranial abscesses, suggesting its versatility in neuro-intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. Stati, G., Migliorino, E., Moneti, M., 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]

The Codman® CerebroFlo® EVD Catheter significantly reduces thrombotic activity by 99% and catheter obstruction by 89% compared to traditional catheters, making it a promising option for managing intraventricular hemorrhages (IVH).

This catheter features a unique Endexo additive that prevents protein adhesion and biomatter accumulation, although its lack of antibiotic coating raises some clinical concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An early analysis of Codman® CerebroFlo® Endexo coated ventricular catheters in the setting of intraventricular hemorrhage. Fiani, B., Jarrah, R.[2022]

The study tested a new circulation device that uses a unique pump design and can be driven by either pneumatic or hydraulic means, showing potential for assisting blood circulation in medical applications.

Experiments conducted on dogs and 17 calves over several days provided insights into surgical techniques, hemodynamic variations, and complications, highlighting the device's feasibility and areas for further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives for pneumatic and hydraulic circulatory assist devices and their application for heart transplantation. Shumakov, VI., Tolpekin, VE., Melemuka, IV., et al.[2019]

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]

References

1. 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]

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

Low incidence of gastrointestinal bleeding and pump thrombosis in patients receiving the INCOR LVAD system in the long-term follow-up. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. [2023]

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

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

5. Italy pubmed.ncbi.nlm.nih.gov

An early analysis of Codman® CerebroFlo® Endexo coated ventricular catheters in the setting of intraventricular hemorrhage. [2022]

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

Perspectives for pneumatic and hydraulic circulatory assist devices and their application for heart transplantation. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

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