Active Removal of IntraCerebral Hematoma Via Active Irrigation

IRRAS60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebral Hemorrhage Intraventricular Hemorrhage

Interventions

IRRAflowDEVICE

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.

EVDDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 years of age 2. Need of EVD 3. Active treatment 4. Signed informed consent obtained a. Based on institutional and country laws 5. Spontaneous ICH with maximum 30 square cm's 6. If needed, normal coagulation profile (PT, PTT, platelet count) 7. Treatment within 72 hours of ictus 8. Ability to administer 2.0 mg of tPA per day for 3 days Exclusion Criteria: 1. Age \< 18 years 2. No need of EVD 3. Patient has fixed and dilated pupils 4. Coagulopathy uncorrectable 5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement) 6. Pregnant women

Locations (1)

Helsinki University

Helsinki, Finland

RECRUITING

Outcomes

Primary Outcomes

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-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.

Time frame: 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.

Time frame: 0-30 days post discharge from hospital

Secondary Outcomes

Procedural Success

Less than or equal to 30% residual clot burden in the ventricular system

Time frame: Intra-Procedural

Technical Success

Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred

Time frame: Intra-Procedural

Technical Success

Percent obstruction of the IRRAflow catheter and EVD catheter

Time frame: Intra-Procedural

Central Contacts

John Unser, MBA

CONTACT

19712195984 john.unser@irras.com

Data from ClinicalTrials.gov

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