Last updated on June 2018

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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Shakeel Chowdhry, MD

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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Eric Peterson, MD

University of Miami / Jackson Memorial Hospital
Miami, FL United States
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Richard Webster Crowley, MD

Rush University Medical Center
Chicago, IL United States
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Andrew Tsung, MD

OSF Saint Francis Medical Center
Peoria, IL United States
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Gary Gallia, MD

Johns Hopkins
Baltimore, MD United States
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M. Ali Aziz-Sultan, MD

Brigham and Women's Hospital
Boston, MA United States
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Jeroen Coppens, MD

Saint Louis University
Saint Louis, MO United States
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Alan Boulos, MD

Albany Medical Center
Albany, NY United States
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Clemens Schirmer, MD

Geisinger Health System
Danville, PA United States
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Kevin Cockroft, MD

Penn State Hershey Medical Center
Hershey, PA United States
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Brian Jankowitz, MD

University of Pittsburgh Medical Center (UPMC)
Pittsburgh, PA United States
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Mark Harrigan, MD

University of Alabama at Birmingham
Birmingham, AL United States
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John D Day, MD

University of Arkansas for Medical Sciences
Little Rock, AR United States
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Lloyd Zucker, MD

Delray Medical Center
Delray Beach, FL United States
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Justin Singer, MD

Spectrum Health
Grand Rapids, MI United States
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Jason Davies, MD

State University of New York, Buffalo
Buffalo, NY United States
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Ning Lin, MD

New York Hospital Queens - Weill Cornell Brain & Spine
Flushing, NY United States
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Jared Knopman, MD

Weill Cornell Brain and Spine Center
New York, NY United States
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James Fleming, MD

OhioHealth Riverside Methodist Hospital
Columbus, OH United States
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Richard Williamson, MD

Allegheny General Hospital
Pittsburgh, PA United States
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Matthew Fusco, MD

Vanderbilt University Medical Center
Nashville, TN United States
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