Clinical trial NCT06649097: Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Official title: Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Hemorrhage
Ventriculitis
Intracranial Abscess
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: IRRAS
First posted: 2024-10-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.).

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

Primary outcomes:
measure: Residual blood volume by post bleed day 5
timeFrame: Post-procedure day 5
measure: Utility weighted modified Rankin Score
timeFrame: End of study, at 6 months
Secondary outcomes:
measure: Rate of blood clearance
timeFrame: Immediately before and after the procedure
measure: Direct hospitalization costs
timeFrame: Discharge, up to 7 days post procedure
measure: NSICU Length of Stay
timeFrame: Discharge, up to 7 days post procedure
measure: Hospital Length of Stay (LOS)
timeFrame: Discharge, up to 7 days post procedure
measure: Proportion of participants needing a shunt
timeFrame: Discharge, up to 7 days post procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christopher Kellner
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Nicholas Brandmeir
role: PRINCIPAL_INVESTIGATOR
References: