What side effects are associated with this type of intervention?

The most common treatments for intraventricular hemorrhage (IVH) that involve externally draining intracranial fluid, such as the IRRAflow® System, can have several side effects. These include infection at the catheter insertion site, bleeding, and blockage of the catheter. Additionally, there is a risk of secondary intraventricular hemorrhage. Other potential complications may include electrolyte imbalances and issues related to the management of intracranial pressure. It is important to monitor patients closely for these side effects to ensure timely intervention and management.

What prior FDA approvals exist?

The IRRAflow® System, which is FDA approved for externally draining intracranial fluid to reduce intracranial pressure, is part of a broader category of treatments for intraventricular hemorrhage (IVH). Similar FDA-approved treatments include standard external ventricular drains (EVDs), which are commonly used to manage intracranial pressure by draining cerebrospinal fluid (CSF) from the ventricles. These devices help alleviate pressure caused by hemorrhage and are a critical component in the management of IVH.

What other types of research exist?

Promising alternatives to the IRRAflow® System for IVH patients include the use of advanced external ventricular drain (EVD) systems with integrated intracranial pressure monitoring, minimally invasive endoscopic surgery for clot evacuation, and novel catheter designs that incorporate antimicrobial properties to reduce infection risk. Additionally, advancements in neuroendoscopic techniques and the development of automated cerebrospinal fluid drainage systems are also being explored as potential alternatives.

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Procedure

IRRAflow® Catheter System for Intraventricular Hemorrhage (DIVE Trial)

N/A

Recruiting

Led By Christopher P Kellner, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years of age

Need of cerebrospinal fluid drainage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours post-procedure

Awards & highlights

DIVE Trial Summary

This trial will compare an FDA-approved catheter (IRRAflow®) to standard catheters for draining brain fluid to reduce pressure. Safety and outcomes will be evaluated.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, infection risk due to invasive procedure, possible malfunction of device leading to inadequate drainage or over-drainage of cerebrospinal fluid.

DIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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I need a procedure to drain fluid from my brain.

DIVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 hours post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 hours post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 hours post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Residual blood volume

Secondary outcome measures

Direct hospitalization costs

Hospital quality metrics

Length of stay in the NSICU

+1 more

DIVE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IRRAflow with Active Fluid Exchange armExperimental Treatment2 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 drainsActive Control1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment mechanism for intraventricular hemorrhage (IVH) involves the external drainage of intracranial fluid to reduce intracranial pressure, as exemplified by the IRRAflow® System. This approach is critical because elevated intracranial pressure can lead to further brain injury, impaired cerebral perfusion, and potentially fatal outcomes. By effectively managing and reducing this pressure, the treatment aims to stabilize the patient's condition, prevent secondary brain damage, and improve overall neurological outcomes.