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

NCT05649904 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Intraventricular Hemorrhage
  • Subarachnoid Hemorrhage
  • Subdural Hematoma
  • Ventriculitis

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.

Sponsors & Collaborators

  • IRRAS

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Patrick Youssef, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649904 on ClinicalTrials.gov