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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Hemorrhage; Ventriculitis; Intracranial Abscess
• Intervention / Treatment: Device: IRRAflow® CNS (Active Fluid Exchange) System

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Sukaina Davdani; Phone Number: (212) 241-2524; Email: sukaina.davdani@mountsinai.org
• Study Contact Backup: Name: Sydney Edwards; Phone Number: (212) 241-2524; Email: Sydney.Edwards@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School Of Medicine At Mount Sinai
      • Contact: Sukaina Davdani; Phone Number: 212-241-2524; Email: Sukaina.Davdani@mountsinai.org
      • Contact: Sydney Edwards; Phone Number: (212) 241-2524; Email: Sydney.Edwards@mountsinai.org
      • Principal Investigator: Christopher Kellner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IRRAflow device; All patients enrolled into the study will undergo treatment with the IRRAflow device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood clearance	Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes	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	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	Discharge, up to 7 days post procedure
Hospital Length of Stay (LOS)	Hospital quality metrics will include length of hospital stay in days	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	Discharge, up to 7 days post procedure

Collaborators and Investigators

• Sponsor: Christopher P Kellner
• Collaborators: IRRAS
• Investigators: Principal Investigator: Christopher Kellner, Icahn School Of Medicine At Mount Sinai; Principal Investigator: Nicholas Brandmeir, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: STUDY-24-01230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No