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

NARecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

February 7, 2023

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Intraventricular HemorrhageSubarachnoid HemorrhageSubdural HematomaVentriculitis
Interventions
DEVICE

IRRAflow 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)."

DEVICE

External Ventricular Drain

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

Trial Locations (1)

43210

RECRUITING

The Ohio State University Wexner Medical Center, Columbus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

IRRAS

INDUSTRY

lead

Ohio State University

OTHER