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

The Ohio State University

Status: Enrolling

Conditions: Subarachnoid Hemorrhage; Intraventricular Hemorrhage; Ventriculitis; Subdural Hematoma

Treatments: Device: External Ventricular Drain; Device: IRRAflow with Active Fluid Exchange System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05649904

2022H0197

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

IRRAflow with Active Fluid Exchange System (IRRAflow)

Experimental group

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.

Treatment:

Device: IRRAflow with Active Fluid Exchange System

External Ventricular Drainage (EVD)

Active Comparator group

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.

Treatment:

Device: External Ventricular Drain