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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 belowSelect...
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
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.
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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
864 Previous Clinical Trials
654,200 Total Patients Enrolled
IRRASIndustry Sponsor
3 Previous Clinical Trials
126 Total Patients Enrolled
Patrick Youssef, MDPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood does not clot normally, and you have very low platelet count.My doctor says I need treatment for a brain bleed or infection.My pupils are fixed and do not respond to light.I have been diagnosed with Moyamoya disease.I have a history of blood clotting issues.I am 18 years old or older.I need a procedure to remove excess fluid due to bleeding or infection in my brain.
Research Study Groups:
This trial has the following groups:- Group 1: External Ventricular Drainage (EVD)
- Group 2: IRRAflow with Active Fluid Exchange System (IRRAflow)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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