RecruitingNot ApplicableNCT05118997

Active Removal of IntraCerebral Hematoma Via Active Irrigation

Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System


Sponsor

IRRAS

Enrollment

60 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a technique called active irrigation via an external ventricular drain (EVD) to help remove blood clots from the brain (intracerebral hemorrhage or ICH). When blood leaks into the brain, it causes pressure and damage. Currently, doctors drain the fluid but the clot itself remains. This study uses a small tube plus a clot-dissolving drug (tPA) to actively wash out the blood. The goal is to determine if this approach improves outcomes compared to standard drainage alone. You may be eligible if... - You are over 18 years old - You have a spontaneous brain bleed (intracerebral hemorrhage) of 30 square cm or less - You need an external ventricular drain (EVD) placed - You are receiving active medical treatment - Treatment can begin within 72 hours of the bleed starting - Your blood clotting tests are normal (if needed) You may NOT be eligible if... - Both your pupils are fixed and dilated - You have a structural cause for the bleed (like an aneurysm or arteriovenous malformation) - You have an uncorrectable bleeding disorder - You do not need an EVD - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIRRAflow

IRRAflow consists of a control unit and disposables (dual-lumen catheter and tube set) to offer an integrated and synchronized active fluid exchange system. Active fluid exchange is the combination of traditional gravity-driven drainage with periodic, controlled irrigation of the catheter probe to exchange any pathological fluid collection with neutral physiological fluids.

DEVICEEVD

An external ventricular drain (EVD), also known as a ventriculostomy or extraventricular drain, is a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid inside the brain is obstructed.


Locations(1)

Helsinki University

Helsinki, Finland

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NCT05118997


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