RecruitingNot ApplicableNCT05649904

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

Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

Sponsor

Ohio State University

Enrollment

240 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Ventriculitis Intraventricular hemorrhage Subarachnoid Hemorrhage Subdural Hematoma

Summary

The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD). Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called External Ventricular Drain and a medical device called IRRAflow with Active Fluid Exchange System for people with intraventricular hemorrhage, subarachnoid hemorrhage, and other related conditions. The study is currently recruiting participants at 1 location.

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 with Active Fluid Exchange System

IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. The intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses).

DEVICEExternal Ventricular Drain

The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.