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

Not Applicable

Recruiting

• Conditions: Intraventricular Hemorrhage; Subdural Hematoma; Ventriculitis; Subarachnoid Hemorrhage
• Interventions: Device: IRRAflow with Active Fluid Exchange System; Device: External Ventricular Drain

• Registration Number: NCT05649904
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-02-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRRAflow with Active Fluid Exchange System (IRRAflow)	IRRAflow with Active Fluid Exchange System	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.
External Ventricular Drainage (EVD)	External Ventricular Drain	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.

Primary Outcome Measures

Name	Time	Method
Rate of revision procedures for the IRRAflow and EVD/Drainage catheters	Immediately post-procedure

Secondary Outcome Measures

Name	Time	Method
Indwell time of EVD/Drainage and IRRAflow Catheter	Immediately post-procedure
Length of ICU stay	Baseline
Rate of shunt dependency	Immediately post-procedure
Rate of catheter-related infection	Immediately post-procedure
Time to clearance of blood or bacterial mass as measured by head CT scan	Immediately post-procedure
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 EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States