IRRAflow® Catheter System for Intraventricular Hemorrhage

(DIVE Trial)

Overseen By Trevor Hardigan, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Fixed pupils, Pregnant, Nursing

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the IRRAflow® System, a catheter system for draining fluid from the brain in individuals with intraventricular hemorrhage. It compares this new system to the standard tubes typically used for the same purpose. The trial seeks participants who have had a brain bleed confirmed by a CT or MRI scan and require brain fluid drainage. Treatment must begin within 72 hours of the bleeding event. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options.

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.

What prior data suggests that the IRRAflow® Catheter System is safe for intraventricular hemorrhage treatment?

Research shows that the IRRAflow® Active Fluid Exchange System is generally well-tolerated by patients. In earlier studies, patients using the IRRAflow system experienced positive safety outcomes. Specifically, it caused fewer blockages and infections compared to traditional drainage methods.

The FDA has approved the IRRAflow system for the procedure under study, strongly indicating its safety for people. This approval confirms that it has been checked for safety and effectiveness for this specific use. Therefore, participants in this trial can feel reassured knowing that previous research and FDA approval support the system's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IRRAflow® Catheter System because it offers a novel approach to managing intraventricular hemorrhage. Unlike traditional external ventricular drains, which passively remove fluid, the IRRAflow system actively exchanges fluids. This active fluid exchange could potentially speed up the removal of blood from the brain, reducing pressure and improving recovery time. By enhancing the efficiency of fluid removal, the IRRAflow system aims to improve patient outcomes more effectively than current standard treatments.

What evidence suggests that the IRRAflow® Catheter System is effective for reducing intracranial pressure?

In this trial, participants will be evaluated using either the IRRAflow® Active Fluid Exchange System or traditional external ventricular drains. Research has shown that the IRRAflow® system quickly clears brain bleeding by actively moving fluid, which is faster than traditional gravity-based methods. Studies have found that this system can reduce complications and improve certain health outcomes. By actively controlling fluid flow, it can lead to better patient recovery. The system reliably speeds up fluid removal from the brain, which is crucial for reducing pressure inside the skull. Overall, the FDA-approved IRRAflow system has shown promise in treating conditions like intraventricular hemorrhage, or bleeding in the brain's ventricles. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher Kellner, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 need a procedure to drain fluid from my brain.

You have bleeding inside your brain as shown on a head CT or MRI scan.

Exclusion Criteria

I am not pregnant or nursing.

My pupils are fixed and do not respond to light.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• IRRAflow® Active Fluid Exchange System
• Traditional extraventricular drain

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.

How Is the Trial Designed?

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.

IRRAflow® Active Fluid Exchange System is already approved in United States for the following indications:

Approved in United States as IRRAflow Active Fluid Exchange System for:

• Intracranial pressure monitoring and externally draining intracranial fluid to reduce intracranial pressure in patients where an external drainage and monitoring system is needed

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

IRRAS

Industry Sponsor

Trials

5

Recruited

730+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05204849

Use of ACTIVE Fluid Exchange to Treat Intraventricular ... The IRRAflow system performs active, controlled fluid exchange, based on the notion that it is faster to wash out IVH, compared to gravity drainage alone.

2. irraflow.com irraflow.com/resources/clinical-data/

Clinical Data IRRAS is committed to providing healthcare professionals with the latest clinical evidence to demonstrate positive outcomes associated with IRRAflow use.

3. irraflow.com irraflow.com/wp-content/uploads/2025/06/2025-Brandmeir-et-al._active_cerebrospinal_fluid_exchange_vs_external.1713.pdf

Active Cerebrospinal Fluid Exchange vs External ... CONCLUSION: ACE therapy with the IRRAflow catheter is associated with fewer complications and improvement in some clinical outcomes. These ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11020765/

Reliability and performance of the IRRAflow® system for ... IRRAflow® (IRRAS AB) is a new technology introduced to accelerate IVH clearance by minimally invasive wash-out. The IRRAflow® system performs active and ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05970549?draw=2&rank=1

NCT05970549 | Intraventricular Catheter System for IVH Study Overview · Device : IRRAflow® Active Fluid Exchange System · Device : Traditional extraventricular drain · Procedure : Non-contrast head CTs.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36581996/

safety and feasibility evaluation of external ventricular ... We hypothesize that the use of active fluid change using the IRRAflow system will be safe and feasible and will reduce the occlusion and infection rates in ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0297131

Reliability and performance of the IRRAflow® system for ... Intraventricular hemorrhage (IVH) is a severe condition with poor outcomes and high mortality rates [1, 2]. Currently, IVH treatment relies on passive drainage ...