Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-25

Study Completion Date

2031-07-31

Brief Summary

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The study is a multi-center prospective cohort, controlled, phase 4 post-market registry evaluating the efficacy and radiographic outcomes associated with the use of the IRRAflow® Active Fluid Exchange System compared to standard of care external ventricular drains.

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Detailed Description

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The IRRAflow system offers automated irrigation, controlled drainage, and ICP monitoring all in one system for the treatment of intracranial hemorrhage - \[Intracerebral hemorrhage (ICH), Intraventricular hemorrhage (IVH), Subarachnoid hemorrhage (SAH), Subdural hematoma (SDH)\], intracranial abscess, and ventriculitis.

The analysis of the IRRAS catheter will occur prospectively if it is determined the patient meets the enrollment criteria. All patients enrolled in the trial will receive additional supportive and medical treatment by choice of the treating physician and in accordance with standard of care. Such treatment includes but is not limited to neurointensive care, neuromonitoring, and surgical or endovascular occlusion of identified sources of intracranial hemorrhage (e.g. vascular anomalies, aneurysms, etc.).

Conditions

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Intracranial Hemorrhage Ventriculitis Intracranial Abscess

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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IRRAflow device

All patients enrolled into the study will undergo treatment with the IRRAflow device

IRRAflow® CNS (Active Fluid Exchange) System

Intervention Type DEVICE

The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.

Interventions

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IRRAflow® CNS (Active Fluid Exchange) System

The IRRAflow system offers automated irrigation, controlled drainage and intracranial pressure (ICP) monitoring all in one system. It consists of three main parts - IRRAflow 2.0 Catheter, IRRAflow Tube Set, IRRAflow Control Unit.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years of age
* Intracranial hemorrhage documented on head CT or MRI scan.
* Indication for active fluid exchange evaluated by treating physician.
* Signed informed consent obtained by patient or Legal Authorized Representative
* Scheduled enrollment and treatment within 72 hours of last known well (LKW)