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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately post-procedure

Awards & highlights

AFFECT Trial Summary

This trial will compare two methods of draining fluid from the brain in patients with various medical conditions.

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.Check my eligibility

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.See study design

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.

AFFECT Trial 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.

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

AFFECT Trial 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

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

Primary outcome measures

Rate of revision procedures for the IRRAflow and EVD/Drainage catheters

Secondary outcome measures

Functional Status - at inclusion and 30 days

Indwell time of EVD/Drainage and IRRAflow Catheter

Length of ICU stay

+4 more

AFFECT 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,380 Total Patients Enrolled

IRRASIndustry Sponsor

3 Previous Clinical Trials

126 Total Patients Enrolled

Patrick Youssef, MDPrincipal InvestigatorOhio State University

Media Library

External Ventricular Drain Clinical Trial Eligibility Overview. Trial Name: NCT05649904 — N/A

Subdural Hematoma Research Study Groups: External Ventricular Drainage (EVD), IRRAflow with Active Fluid Exchange System (IRRAflow)

Subdural Hematoma Clinical Trial 2023: External Ventricular Drain Highlights & Side Effects. Trial Name: NCT05649904 — N/A

External Ventricular Drain 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649904 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots remaining in this medical experiment?

"According to the clinicaltrials.gov website, this research initiative is seeking participants and was initially posted on February 7th 2023 with its last update occurring April 5th of the same year."

Answered by AI

Could you provide an estimate of the overall number of participants in this experiment?

"Affirmative. Clinicaltrials.gov data attests that this scientific investigation, which was originally published on February 7th 2023, is currently recruiting participants. A total of 240 individuals are sought at one clinical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

Patrick Youssef 2023. "AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05649904.

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