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

NCT05649904 | Recruiting FDA Device

• 1 other identifier: 2022H0197
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of revision procedures for the IRRAflow and EVD/Drainage catheters

  Immediately post-procedure

Secondary Outcomes (11)

• Time to clearance of blood or bacterial mass as measured by head CT scan

  Immediately post-procedure

• Rate of catheter-related infection

  Immediately post-procedure

• Length of ICU stay

  Baseline

• Rate of shunt dependency

  Immediately post-procedure

• Indwell time of EVD/Drainage and IRRAflow Catheter

  Immediately post-procedure

Study Arms (2)

IRRAflow with Active Fluid Exchange System (IRRAflow)

EXPERIMENTAL

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.

Device: IRRAflow with Active Fluid Exchange System

External Ventricular Drainage (EVD)

ACTIVE COMPARATOR

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.

Device: External Ventricular Drain

Interventions

IRRAflow with Active Fluid Exchange System 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).

Also known as: IRRAflow

IRRAflow with Active Fluid Exchange System (IRRAflow)

External Ventricular Drain DEVICE

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

Also known as: EVD

External Ventricular Drainage (EVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years of age
• Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
• Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
• Signed informed consent obtained by subject or Legally Authorized Representative

You may not qualify if:

• Subject has fixed and dilated pupils
• Pregnant women
• Presence of Moyamoya
• History or presence of clotting disorder.
• Platelet count less than 100,000, INR greater than 1.4

Sponsors & Collaborators

• Ohio State University: lead
• IRRAS: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hematoma, Subdural

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhage, Traumatic; Craniocerebral Trauma; Trauma, Nervous System; Hematoma; Wounds and Injuries

Study Officials

• Patrick Youssef, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edouard Beliaire

CONTACT

6143666936; edouard.belizaire@osumc.edu

Patrick Youssef, MD

CONTACT

6143666590; patrick.youssef@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Neurological Surgery

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 14, 2022
• Study Start: February 7, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)