Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChristopher P Kellner
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
GCS ≤ 5
Pregnancy
Fixed and dilated pupil
Life-threatening medical condition
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: IRRAflow device1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Post-procedure day 52
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
Time frame
End of study, at 6 monthsSecondary outcomes
1
Rate of blood clearance
Rate of blood clearance will be calculated based on pre- and post-procedure blood volumes
Time frame
Immediately before and after the procedure2
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
Time frame
Discharge, up to 7 days post procedure3
NSICU Length of Stay
Hospital quality metrics will include length of neonatal surgery intensive care unit (NSICU) stay in days
Time frame
Discharge, up to 7 days post procedure4
Hospital Length of Stay (LOS)
Hospital quality metrics will include length of hospital stay in days
Time frame
Discharge, up to 7 days post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Christopher P Kellner
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
IRRAS
Collaborator
Source ClinicalTrials.gov