Intracranial HemorrhageCRYSTALNCT06649097
Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
An observational study of Intracranial Hemorrhage and Ventriculitis, run by Christopher P Kellner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhage, Ventriculitis, Intracranial Abscess
- What is being tested?
- IRRAflow® CNS (Active Fluid Exchange) System
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to Jul 2031
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- GCS ≤ 5
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sukaina Davdani, 212-241-2524, Sukaina.Davdani@mountsinai.org
Sydney Edwards, (212) 241-2524, Sydney.Edwards@mountsinai.org
About this study
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.
Read the 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.).
- Conditions
- Intracranial Hemorrhage, Ventriculitis, Intracranial Abscess
- Being tested
- IRRAflow® CNS (Active Fluid Exchange) System
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRRAflow® CNS (Active Fluid Exchange) SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| IRRAflow device | All patients enrolled into the study will undergo treatment with the IRRAflow device Receives: Device: IRRAflow® CNS (Active Fluid Exchange) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: End of study, at 6 months
Secondary outcomes (5)
Rate of blood clearance
Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes
Measured: Immediately before and after the procedure
Direct hospitalization costs
Direct hospitalization costs will be determined based on the hospital-reported cost of care for the entirety of the patient's hospital stay
Measured: Discharge, up to 7 days post procedure
NSICU Length of Stay
Hospital quality metrics will include length of neonatal surgery intensive care unit (NSICU) stay in days
Measured: Discharge, up to 7 days post procedure
Hospital Length of Stay (LOS)
Hospital quality metrics will include length of hospital stay in days
Measured: Discharge, up to 7 days post procedure
Proportion of participants needing a shunt
Proportion of participants needing a shunt will be calculated to determine how many patients needed a shunt to treat their hydrocephalus
Measured: Discharge, up to 7 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start25 Sep 2025
- Primary completionJan 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Christopher P Kellner
- Sponsor type
- University, hospital or other
- Collaborators
- IRRAS
- Responsible party
- Sponsor-investigator, Christopher P Kellner, Icahn School of Medicine at Mount Sinai
- Investigators
- Christopher Kellner, Principal investigator, Icahn School of Medicine at Mount SinaiNicholas Brandmeir, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649097
- Sponsor's protocol ID
- STUDY-24-01230
- Acronym
- CRYSTAL
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2024
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
- ClinicalTrials.gov ID
- NCT06649097
- Acronym / sponsor ID
- CRYSTAL / STUDY-24-01230
- Conditions
- Intracranial Hemorrhage, Ventriculitis, Intracranial Abscess
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Christopher P KellnerUniversity, hospital or other
- Collaborators
- IRRAS
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IRRAflow device | – | Device: IRRAflow® CNS (Active Fluid Exchange) SystemAll patients enrolled into the study will undergo treatment with the IRRAflow device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- GCS ≤ 5
- Pregnancy
- Fixed and dilated pupil
- Life-threatening medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRRAflow® CNS (Active Fluid Exchange) SystemThe 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. | Device | IRRAflow device |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Kellner principal investigator
Icahn School of Medicine at Mount Sinai
Nicholas Brandmeir principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhage and Ventriculitis, run by Christopher P Kellner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sukaina Davdani ((212) 241-2524, Sukaina.Davdani@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual blood volume by post bleed day 5 (time frame: Post-procedure day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.