Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IRRAflow® CNS (Active Fluid Exchange) System.
- Who it may be relevant to
- Registry conditions: Intracranial Hemorrhage, Ventriculitis, Intracranial Abscess. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.).
Interventions
- Device 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.
Primary outcome measures
- Residual blood volume by post bleed day 5 [Time frame: Post-procedure day 5]
- Utility weighted modified Rankin Score [Time frame: End of study, at 6 months]
Secondary outcome measures (5)
- Rate of blood clearance [Time frame: Immediately before and after the procedure]
- Direct hospitalization costs [Time frame: Discharge, up to 7 days post procedure]
- NSICU Length of Stay [Time frame: Discharge, up to 7 days post procedure]
- Hospital Length of Stay (LOS) [Time frame: Discharge, up to 7 days post procedure]
- Proportion of participants needing a shunt [Time frame: Discharge, up to 7 days post procedure]
Eligibility criteria
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)
Exclusion criteria
- GCS ≤ 5
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT06649097 · STUDY-24-01230