Last updated on April 2017

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

Brief description of study

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.

Detailed Study Description

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 a 10% 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.

Clinical Study Identifier: NCT02880878

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Gabriel Zada, MD

University of Southern California (USC)
Los Angeles, CA United States
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Michael Alexander, MD

Cedars-Sinai Medical Center
Los Angeles, CA United States
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Daniel Barrow, MD

Emory University School of Medicine - Primary Site & Scientific Leadership Team
Atlanta, GA United States
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Boris Jancan, MD, CCRP

NorthShore University Health System
Evanston, IL United States
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Mitesh Shah, MD

Indiana University
Indianapolis, IN United States
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Michael Chicoine, MD

Washington University (Barnes Jewish)
Saint Louis, MO United States
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Deanna Sasaki-Adams, MD

The University of North Carolina at Chapel Hill
Chapel Hill, NC United States
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Mark Bain, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Bradley Bohnstedt, MD

University of Oklahoma
Oklahoma City, OK United States
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