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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
Must not have
Pregnant or nursing women (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy)
Patient has fixed and dilated pupils
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 hours post-procedure
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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.
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 drain fluid from my brain.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or nursing.
Select...
My pupils are fixed and do not respond to light.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Residual blood volume
Secondary study objectives
Direct hospitalization costs
Hospital quality metrics
Length of stay in the NSICU
+1 moreAwards & 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 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.
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.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
894 Previous Clinical Trials
537,210 Total Patients Enrolled
IRRASIndustry Sponsor
3 Previous Clinical Trials
358 Total Patients Enrolled
Christopher P Kellner, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
416 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or nursing.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.You have bleeding inside your brain as shown on a head CT or MRI scan.My pupils are fixed and do not respond to light.I can start treatment within 3 days of my stroke symptoms starting.
Research Study Groups:
This trial has the following groups:- Group 1: IRRAflow with Active Fluid Exchange arm
- Group 2: Retrospective analysis of traditional external ventricular drains
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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