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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis

Intervention / Treatment
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* Device: IRRAflow with Active Fluid Exchange System
* Device: External Ventricular Drain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRRAflow with Active Fluid Exchange System (IRRAflow)<br>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<br>* 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).<br>* Other names: IRRAflow;|
| Active Comparator: External Ventricular Drainage (EVD)<br>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<br>* The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.<br>* Other names: EVD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 
| Mortality rates - intraprocedural and at 30 days |  | 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 |