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

NCT ID: NCT05649904

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IRRAflow with Active Fluid Exchange System (IRRAflow)

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 Type: EXPERIMENTAL

IRRAflow with Active Fluid Exchange System

Intervention Type: DEVICE

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).

External Ventricular Drainage (EVD)

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.

Group Type: ACTIVE_COMPARATOR

External Ventricular Drain

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

External Ventricular Drain

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

Intervention Type: DEVICE

Other Intervention Names

IRRAflow; EVD

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years of age

2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis

3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis

4. Signed informed consent obtained by subject or Legally Authorized Representative

Exclusion Criteria

1. Subject has fixed and dilated pupils

2. Pregnant women

3. Presence of Moyamoya

4. History or presence of clotting disorder.

5. Platelet count less than 100,000, INR greater than 1.4

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRRAS

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Patrick Youssef

Clinical Assistant Professor of Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Youssef, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Edouard Beliaire

Role: CONTACT

edouard.belizaire@osumc.edu

6143666936

Patrick Youssef, MD

Role: CONTACT

patrick.youssef@osumc.edu

6143666590

Facility Contacts

Edouard Belizaire

Role: primary

edouard.belizaire@osumc.edu

Uchechi Okafor

Role: backup

Uchechi.Okafor@osumc.edu

Other Identifiers

2022H0197

Identifier Type: -

Identifier Source: org_study_id