What is the mechanism of action of this treatment?

Subdural hematoma is commonly treated through surgical interventions such as craniotomy or burr hole drainage, which aim to remove the accumulated blood and relieve pressure on the brain. The IRRAflow system, an advanced treatment under study, uses Active Controlled Irrigation and Drainage to evacuate cerebrospinal fluid, blood, and harmful bacteria from the subdural space. This method contrasts with traditional Passive External Ventricular Drainage (EVD) by actively controlling the flow, potentially leading to more efficient and safer removal of fluids. Understanding these mechanisms is crucial for patients as it informs them about the potential benefits and risks of different treatment options, helping them make informed decisions in collaboration with their healthcare providers.

What side effects are associated with this type of intervention?

The most common treatments for subdural hematoma include Active Controlled Irrigation and Drainage (such as the IRRAflow device) and Passive External Ventricular Drainage (EVD). Known side effects of these treatments can include infection, bleeding, and damage to surrounding brain tissue. Additionally, there may be risks associated with the surgical procedure itself, such as anesthesia complications and postoperative pain. Active Controlled Irrigation and Drainage may also carry a risk of over-drainage or under-drainage of cerebrospinal fluid, which can lead to further complications.

What prior FDA approvals exist?

The FDA has approved various treatments for subdural hematoma, primarily focusing on surgical interventions such as craniotomy and burr hole drainage. These procedures involve the physical removal of blood to relieve pressure on the brain. While traditional methods like passive external ventricular drainage (EVD) are commonly used, newer technologies such as the IRRAflow system, which combines active controlled irrigation and drainage, are being studied for their efficacy and safety. These advanced systems aim to improve outcomes by more effectively removing cerebrospinal fluid, blood, and harmful bacteria from the brain's compartments.

What other types of research exist?

Promising novel alternatives to IRRAflow for subdural hematoma patients include minimally invasive surgical techniques such as endoscopic evacuation, the use of middle meningeal artery embolization to reduce recurrence, and advanced neuroimaging-guided interventions. These methods aim to improve outcomes by reducing invasiveness and enhancing precision in treatment.

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IRRAflow Drainage for Brain Hemorrhage (AFFECT Trial)

N/A

Recruiting

Led By Patrick Youssef, MD

Research Sponsored by Ohio State University

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 drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis

Must not have

Subject has fixed and dilated pupils

Presence of Moyamoya

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post subject discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called IRRAflow, which actively cleans out fluid, blood, and bacteria from certain areas in the brain. It targets patients with brain bleeding or infections. The device works by flushing out harmful substances to keep the brain areas clean and reduce complications.

Who is the study for?

Adults over 18 needing drainage for brain conditions like intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma, or ventriculitis can join. They must need active treatment and give informed consent. Those with fixed dilated pupils, Moyamoya disease, clotting disorders, pregnancy, low platelets or high INR can't participate.

What is being tested?

The study compares two methods of draining harmful fluids from the brain: IRRAflow (an active system) versus a standard passive drain (EVD). Participants are randomly chosen to receive one method and monitored for a month to see which is safer and more effective.

What are the potential side effects?

Potential side effects may include discomfort at the drainage site, infection risk due to device insertion into the brain space, possible bleeding complications related to the procedure itself or equipment malfunction.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Select...

I need a procedure to remove excess fluid due to bleeding or infection in my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My pupils are fixed and do not respond to light.

Select...

I have been diagnosed with Moyamoya disease.

Select...

I have a history of blood clotting issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post subject discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post subject discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post subject discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Functional Status - at inclusion and 30 days

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: IRRAflow with Active Fluid Exchange System (IRRAflow)Experimental Treatment1 Intervention

Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.

Group II: External Ventricular Drainage (EVD)Active Control1 Intervention

Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.

0 / 5Eligibility 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

Subdural hematoma is commonly treated through surgical interventions such as craniotomy or burr hole drainage, which aim to remove the accumulated blood and relieve pressure on the brain. The IRRAflow system, an advanced treatment under study, uses Active Controlled Irrigation and Drainage to evacuate cerebrospinal fluid, blood, and harmful bacteria from the subdural space. This method contrasts with traditional Passive External Ventricular Drainage (EVD) by actively controlling the flow, potentially leading to more efficient and safer removal of fluids. Understanding these mechanisms is crucial for patients as it informs them about the potential benefits and risks of different treatment options, helping them make informed decisions in collaboration with their healthcare providers.