Icahn School of Medicine at Mount Sinai
New York, 10029, United States
Location status: Recruiting
Location contact
Christopher Kellner
PRINCIPAL_INVESTIGATOR
Sukaina Davdani
CONTACT
Sydney Edwards
CONTACT
Recruiting
NCT Number: NCT06649097
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
IRRAflow® CNS (Active Fluid Exchange) System
DeviceThe 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 outcomes
-
Residual blood volume by post bleed day 5
Time frame: Post-procedure day 5
The residual blood volume at day 5 will be calculated to determine the efficacy of the IRRAflow system compared to other external ventricular drains (EVDs)
-
Utility weighted modified Rankin Score
Time frame: End of study, at 6 months
Modified Rankin Scale score at 6 months will be collected to determine patient functional outcomes at 6 months. Scores range from 0 to 6, with 0 indicating no disability and 6 indicating death
Secondary outcomes
-
Rate of blood clearance
Time frame: Immediately before and after the procedure
Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes
-
Direct hospitalization costs
Time frame: Discharge, up to 7 days post procedure
Direct hospitalization costs will be determined based on the hospital-reported cost of care for the entirety of the patient's hospital stay
-
NSICU Length of Stay
Time frame: Discharge, up to 7 days post procedure
Hospital quality metrics will include length of neonatal surgery intensive care unit (NSICU) stay in days
-
Hospital Length of Stay (LOS)
Time frame: Discharge, up to 7 days post procedure
Hospital quality metrics will include length of hospital stay in days
-
Proportion of participants needing a shunt
Time frame: Discharge, up to 7 days post procedure
Proportion of participants needing a shunt will be calculated to determine how many patients needed a shunt to treat their hydrocephalus
Study contacts
Contact information is provided by the study sponsor or research team.
Sukaina Davdani
CONTACT
Sydney Edwards
CONTACT
Sponsors and collaborators
Lead sponsor
Christopher P Kellner
Other
Collaborators
- IRRAS
Registry information
Acronym: CRYSTAL
Important dates
- Study start
- 2025
- Primary completion
- 2031
- Study completion
- 2031
- First posted
- Oct 18, 2024
- Registry last updated
- Oct 28, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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