Active Removal of IntraCerebral Hematoma Via Active Irrigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRRAS
About this trial
Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years of age
Need of EVD
Active treatment
Signed informed consent obtained
Disqualifiers
Age < 18 years
No need of EVD
Patient has fixed and dilated pupils
Coagulopathy uncorrectable
Trial design
Design model
Factorial
Treatments tested in this trial
IRRAflow
DeviceIRRAflow consists of a control unit and disposables (dual-lumen catheter and tube set) to offer an integrated and synchronized active fluid exchange system. Active fluid exchange is the combination of traditional gravity-driven drainage with periodic, controlled irrigation of the catheter probe to exchange any pathological fluid collection with neutral physiological fluids.
EVD
DeviceAn external ventricular drain (EVD), also known as a ventriculostomy or extraventricular drain, is a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid inside the brain is obstructed.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Treatment Arm #1Experimental treatment 1 intervention
Group B: Treatment Arm #2Experimental treatment 1 intervention
Group C: Treatment Arm #3Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy and safety of evacuation of intraventricular hematoma by Active External Ventricular Drainage (IRRAflow) with tPA administration compared to Passive External Ventricular Drainage (EVD) with tPA administration.
Efficacy is defined as the efficiency of each arm to remove the hematoma (70% cm3). Safety is measured as the frequency of bacterial central nervous system (measures as positive bacterial growth in cerebrospinal fluid), symptomatic brain bleeds (clinical symptoms drop in modified Rankin scale), and mortality (death).
Time frame
Intra-procedure2
Radiographic evaluation of ventricular blood removal as measured by head CT scan
Change in blood volume (cm3) measured between stability scan and end of treatment scan.
Time frame
Intra-procedure3
Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale.
Defined as the comparison of patients outcomes between the three groups as measured by Glasgow Coma Scale, extended Glasgow Outcome Scale, and modified Rankin Scale.
Time frame
0-30 days post discharge from hospitalSecondary outcomes
1
Procedural Success
Less than or equal to 30% residual clot burden in the ventricular system
Time frame
Intra-Procedural2
Technical Success
Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred
Time frame
Intra-Procedural3
Technical Success
Percent obstruction of the IRRAflow catheter and EVD catheter
Time frame
Intra-Procedural4
Safety - Catheter misplacement
Measurement of if the catheter needs to be re-inserted or re-positioned.
Time frame
Intra-ProceduralOther outcomes
1
Length of ICU stay (days)
Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU
Time frame
Intra-Procedural2
Length of overall length (days) of hospital stay
Time (days) the patient is admitted to the hospital till the patient is discharged from the hospital
Time frame
Intra-Procedural3
Rate of mortality during treatment
Percentage of patients having a mortality event during active treatment
Time frame
Intra-Procedural4
Rate of shunt dependency
Percentage of patients that require a shunt after treatment
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRRAS
Lead sponsor
University of Helsinki
Collaborator
Northwestern University
Collaborator
West Virginia University
Collaborator
Klinikum Bergmannstrost
Collaborator
Stony Brook University Hospital
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Buffalo General Medical Center
Collaborator
Source ClinicalTrials.gov