This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (\<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.
The ENRICH trial will compare the outcomes between early surgical intervention using the BrainPath® Approach (i.e., MIPS) and a medically managed cohort. The integrated surgical approach includes a combination of available technologies, including the FDA-cleared NICO BrainPath® for non-disruptive access and NICO Myriad® to achieve the goal of maximum clot evacuation. The medically managed cohort will be treated according the Clinical Standardization Guidelines (CSG) as adapted by Emory University from the 2015 AHA/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale (mRS). Data suggests improved mortality rates and potential functional benefits of surgical ICH evacuation. The methodology proposed for this trial was tested in a preliminary series of 39 patients treated for supratentorial spontaneous ICH and retrospectively reviewed (Labib et al.). These results were replicated in a single center retrospective series of 18 patients (Bauer et al.). Despite positive results of both studies and the widely accepted benefit of the BrainPath Approach (i.e., MIPS) for subcortical lesions, stronger evidence supporting the use of these techniques in ICH is needed for the technique to become universally validated. CONTACTS: Sponsor - Primary: Penny Sekerak, MBA, BA, RN (317) 569-1229, Penny.Sekerak@niconeuro.com Sponsor - Backup: Jennifer Carroll, (317) 709-2466, Jennifer.Carroll@niconeuro.com
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Early Minimally Invasive Parafascicular Surgery (MIPS)
Functional Improvement - mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
Time frame: 180 days
Safety - Procedure-Related Mortality
Safety will be assessed by determining procedure-related mortality by comparing rates of mortality at 30 days for patients that underwent MIPS with medically treated patients
Time frame: 30 days
Safety - Hemorrhage Volume
Safety will be assessed by evaluating whether MIPS does not result in an increase in hemorrhage volume between index CT and 24-hour follow-up CT as compared to medically treated patients
Time frame: 24 hours
Economic
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS
Time frame: 30, 90, 120, and 180 days
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute (BNI)
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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Delray Beach, Florida, United States
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Mayo Clinic
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Miami, Florida, United States
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