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

Sponsor

Ohio State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05649904

Collaborator

IRRAS (Industry)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraventricular Hemorrhage Subarachnoid Hemorrhage Subdural Hematoma Ventriculitis	Device: IRRAflow with Active Fluid Exchange System Device: External Ventricular Drain	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of revision procedures for the IRRAflow and EVD/Drainage catheters [Immediately post-procedure]

Secondary Outcome Measures

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]
Functional Status - at inclusion and 30 days [30 days post subject discharge]
The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).
Mortality rates - intraprocedural and at 30 days [30 days post subject discharge]
Functional Status - at inclusion and 30 days [30 days post subject discharge]
The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).
Functional Status - at inclusion and 30 days [30 days post subject discharge]
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.
Functional Status - at inclusion and 30 days [30 days post subject discharge]
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.
Functional Status - at inclusion and 30 days [30 days post subject discharge]
The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ohio State University
IRRAS

Investigators

Principal Investigator: Patrick Youssef, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrick Youssef, Clinical Assistant Professor of Neurological Surgery, Ohio State University

ClinicalTrials.gov Identifier:

NCT05649904

Other Study ID Numbers:

2022H0197

First Posted:

Dec 14, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Study Results

No Results Posted as of Dec 20, 2022