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

Primary Purpose

Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IRRAflow with Active Fluid Exchange System
External Ventricular Drain
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraventricular Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IRRAflow with Active Fluid Exchange System (IRRAflow)

External Ventricular Drainage (EVD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to clearance of blood or bacterial mass as measured by head CT scan
Rate of catheter-related infection
Length of ICU stay
Rate of shunt dependency
Indwell time of EVD/Drainage and IRRAflow Catheter
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).
Mortality rates - intraprocedural and at 30 days
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).
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.
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.
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).

Full Information

First Posted
October 24, 2022
Last Updated
April 5, 2023
Sponsor
Ohio State University
Collaborators
IRRAS
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1. Study Identification

Unique Protocol Identification Number
NCT05649904
Brief Title
AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis
Acronym
AFFECT
Official Title
Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
IRRAS

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IRRAflow with Active Fluid Exchange System (IRRAflow)
Arm Type
Experimental
Arm Description
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.
Arm Title
External Ventricular Drainage (EVD)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IRRAflow with Active Fluid Exchange System
Other Intervention Name(s)
IRRAflow
Intervention Description
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
Intervention Name(s)
External Ventricular Drain
Other Intervention Name(s)
EVD
Intervention Description
The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.
Primary Outcome Measure Information:
Title
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters
Time Frame
Immediately post-procedure
Secondary Outcome Measure Information:
Title
Time to clearance of blood or bacterial mass as measured by head CT scan
Time Frame
Immediately post-procedure
Title
Rate of catheter-related infection
Time Frame
Immediately post-procedure
Title
Length of ICU stay
Time Frame
Baseline
Title
Rate of shunt dependency
Time Frame
Immediately post-procedure
Title
Indwell time of EVD/Drainage and IRRAflow Catheter
Time Frame
Immediately post-procedure
Title
Functional Status - at inclusion and 30 days
Description
The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).
Time Frame
30 days post subject discharge
Title
Mortality rates - intraprocedural and at 30 days
Time Frame
30 days post subject discharge
Title
Functional Status - at inclusion and 30 days
Description
The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).
Time Frame
30 days post subject discharge
Title
Functional Status - at inclusion and 30 days
Description
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.
Time Frame
30 days post subject discharge
Title
Functional Status - at inclusion and 30 days
Description
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.
Time Frame
30 days post subject discharge
Title
Functional Status - at inclusion and 30 days
Description
The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).
Time Frame
30 days post subject discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Adams
Phone
6146854484
Email
victoria.adams@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Youssef, MD
Phone
6143666590
Email
patrick.youssef@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Youssef, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Adams
Email
victoria.adams@osumc.edu
First Name & Middle Initial & Last Name & Degree
Megan Frost
Email
megan.frost@osumc.edu
First Name & Middle Initial & Last Name & Degree
Patrick Youssef
First Name & Middle Initial & Last Name & Degree
Shahid Nimjee
First Name & Middle Initial & Last Name & Degree
Ciaran Powers

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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