Active Removal of IntraCerebral Hematoma Via Active Irrigation

Study Overview
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Brief Summary
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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.

Detailed Description
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The ARCH study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with IRRAflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tPA. This might affect the patient neurological outcome assessed by GCS and mRankin scale.

Official Title
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Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System

Conditions
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Cerebral Hemorrhage, Intraventricular Hemorrhage

Intervention / Treatment
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* Device: IRRAflow
* Device: EVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years of age Need of EVD Active treatment Signed informed consent obtained a. Based on institutional and country laws Spontaneous ICH with maximum 30 square cm's If needed, normal coagulation profile (PT, PTT, platelet count) Treatment within 72 hours of ictus Ability to administer 2.0 mg of tPA per day for 3 days Exclusion Criteria: Age < 18 years No need of EVD Patient has fixed and dilated pupils Coagulopathy uncorrectable Vascular pathology (e.g. Aneurysm involvement, AVM involvement) Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm #1<br>IRRAflow with manual tPA administration followed by Active Fluid Exchange | Device: IRRAflow<br>* IRRAflow 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.<br>|
| Experimental: Treatment Arm #2<br>IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange | Device: IRRAflow<br>* IRRAflow 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.<br>|
| Active Comparator: Treatment Arm #3<br>Standard EVD with manual tPA administration | Device: EVD<br>* An 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Intra-procedure | 
| 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. | Intra-procedure | 
| 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. | 0-30 days post discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Less than or equal to 30% residual clot burden in the ventricular system | Intra-Procedural | 
| Technical Success | Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred | Intra-Procedural | 
| Technical Success | Percent obstruction of the IRRAflow catheter and EVD catheter | Intra-Procedural | 
| Safety - Catheter misplacement | Measurement of if the catheter needs to be re-inserted or re-positioned. | Intra-Procedural | 
| Safety - Infection | Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis | Intra-Procedural | 
| Safety - Bleeding events | Comparison of new bleeding events on routine neuroimaging | Intra-Procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemorrhage