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



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:10/28/2018
Start Date:December 2016
End Date:July 2020
Contact:Penny Sekerak, MBA, BA, RN
Email:Penny.Sekerak@niconeuro.com
Phone:317-660-7118

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ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH).

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 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.

Inclusion Criteria:

- Age 18-80 years

- Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH

- Manual ICH volume between 30 - 80 mL

- Study intervention can reasonably be initiated within 24 hours after the onset of
stroke symptoms. If the actual time of onset is unclear, then the onset will be
considered the time that the subject was last known to be well

- Glasgow Coma Score (GCS) 5 - 14

- Historical Modified Rankin Score 0 or 1

Exclusion Criteria:

- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya
disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic
infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging

- NIHSS < 5

- Bilateral fixed dilated pupils

- Extensor motor posturing

- Intraventricular extension of the hemorrhage is visually estimated to involve >50% of
either of the lateral ventricles

- Primary Thalamic ICH

- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar

- Use of anticoagulants that cannot be rapidly reversed

- Evidence of active bleeding involving a retroperitoneal, gastrointestinal,
genitourinary, or respiratory tract site

- Uncorrected coagulopathy or known clotting disorder

- Platelet count < 75,000, International Normalized Ratio (INR) > 1.4 after correction

- Patients requiring long-term anti-coagulation that needs to be initiated < 5 days from
index ICH

- End stage renal disease

- Patients with a mechanical heart valve

- End-stage liver disease

- History of drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements

- Positive urine or serum pregnancy test in female subjects without documented history
of surgical sterilization or is post-menopausal

- Known life-expectancy of less than 6 months

- No reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures
only prior to randomization

- Participation in a concurrent interventional medical investigation or clinical trial.

- Inability or unwillingness of subject or legal guardian/representative to give written
informed consent

- Homelessness or inability to meet follow up requirements
We found this trial at
31
sites
Flushing, New York 11355
Principal Investigator: Ning Lin, MD
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Principal Investigator: Gustavo Pradilla, MD
Phone: 877-572-5511
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Atlanta, GA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Gary Gallia, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mark Harrigan, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: M. Ali Aziz-Sultan, MD
Phone: 617-732-8527
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Deanna Sasaki-Adams, MD
Phone: 919-843-8797
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Mitesh Shah, MD
Phone: 317-396-1254
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: John D Day, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Michael Alexander, MD
Phone: 310-423-5067
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1611 Northwest 12th Avenue
Miami, Florida 33136
Principal Investigator: Eric Peterson, MD
Phone: 305-585-2099
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Miami, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Matthew Fusco, MD
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Albany, New York 12208
Principal Investigator: Alan Boulos, MD
Phone: 518-262-5868
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Buffalo, New York 14222
Principal Investigator: Jason Davies, MD
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Richard Webster Crowley, MD
Phone: 312-942-1114
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Mark Bain, MD
Phone: 216-444-3120
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43214
Principal Investigator: James Fleming, MD
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Danville, Pennsylvania 17822
Principal Investigator: Clemens Schirmer, MD
Phone: 570-214-2432
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Delray Beach, Florida 33431
Principal Investigator: Lloyd Zucker, MD
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Evanston, Illinois 60201
Principal Investigator: Shakeel Chowdhry, MD
Phone: 847-570-4224
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Grand Rapids, Michigan 49503
Principal Investigator: Justin Singer, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Kevin Cockroft, MD
Phone: 717-531-0003
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Los Angeles, California 90007
Principal Investigator: Gabriel Zada, MD
Phone: 323-442-7544
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New York, New York 10065
Principal Investigator: Jared Knopman, MD
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Bradley Bohnstedt, MD
Phone: 405-271-4658
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Peoria, Illinois 61637
Principal Investigator: Andrew Tsung, MD
Phone: 309-624-3240
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Brian Jankowitz, MD
Phone: 412-605-3959
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Principal Investigator: Richard Williamson, MD
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
Principal Investigator: Michael Chicoine, MD
Phone: 314-362-3473
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Saint Louis, Missouri 63110
Principal Investigator: Jeroen Coppens, MD
Phone: 314-977-4751
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