Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
CRYSTAL
1 other identifier
observational
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
October 28, 2025
October 1, 2025
5.3 years
October 16, 2024
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Residual blood volume by post bleed 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)
Post-procedure day 5
Utility weighted modified Rankin Score
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
End of study, at 6 months
Secondary Outcomes (5)
Rate of blood clearance
Immediately before and after the procedure
Direct hospitalization costs
Discharge, up to 7 days post procedure
NSICU Length of Stay
Discharge, up to 7 days post procedure
Hospital Length of Stay (LOS)
Discharge, up to 7 days post procedure
Proportion of participants needing a shunt
Discharge, up to 7 days post procedure
Study Arms (1)
IRRAflow device
All patients enrolled into the study will undergo treatment with the IRRAflow device
Interventions
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.
Eligibility Criteria
The patient population for this study will be comprised of up to 250 patients with primary diagnosis of intracranial hemorrhage (SAH, ICH, IVH, SDH), ventriculitis, or intracranial abscess.
You may qualify if:
- 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)
You may not qualify if:
- GCS ≤ 5
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christopher P Kellnerlead
- IRRAScollaborator
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Kellner
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Nicholas Brandmeir
West Virginia University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Neurosurgery
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 18, 2024
Study Start
September 25, 2025
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
July 1, 2031
Last Updated
October 28, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share
Upon the completion of the study, Mount Sinai's data management team will clean and analyze all data in preparation of manuscript writing and publication. The intention will be to publish together between the principal investigator and the sponsor. Following publication, Mount Sinai will archive and store all associated data on its cloud-based system.