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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage; Intraventricular Hemorrhage; Ventriculitis; Subdural Hematoma
• Intervention / Treatment: Device: IRRAflow with Active Fluid Exchange System; Device: External Ventricular Drain

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Adams; Phone Number: 6146854484; Email: victoria.adams@osumc.edu
• Study Contact Backup: Name: Patrick Youssef, MD; Phone Number: 6143666590; Email: patrick.youssef@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Victoria Adams; Email: victoria.adams@osumc.edu
      • Contact: Megan Frost; Email: megan.frost@osumc.edu
      • Principal Investigator: Patrick Youssef
      • Sub-Investigator: Shahid Nimjee
      • Sub-Investigator: Ciaran Powers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).; Other Names: IRRAflow
Active Comparator: 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.	Device: External Ventricular Drain; The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.; Other Names: EVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters	Immediately post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality rates - intraprocedural and at 30 days		30 days post subject discharge
Functional Status - at inclusion and 30 days	The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).	30 days post subject discharge
Functional Status - at inclusion and 30 days	The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).	30 days post subject discharge
Functional Status - at inclusion and 30 days	The Barthel Index will be used to assess functional status. Scores for this assessment tool range from 0 - 100, with a higher number indicating a better functional status.	30 days post subject discharge
Functional Status - at inclusion and 30 days	The Stroke Impact Scale will be used to assess functional status. Scores for this scale range from 0 - 100, with a higher number indicating a better functional status.	30 days post subject discharge
Functional Status - at inclusion and 30 days	The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).	30 days post subject discharge

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: IRRAS
• Investigators: Principal Investigator: Patrick Youssef, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hemorrhage; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: 2022H0197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes