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

May 8, 2023 updated by: Nico Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 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

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute (BNI)
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California (USC)
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Jacksonville
      • Miami, Florida, United States, 33136
        • University of Miami / Jackson Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Emory University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University
      • Saint Louis, Missouri, United States, 63110
        • Washington University (Barnes Jewish)
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Bronx, New York, United States, 10467
        • Montefiore
      • Buffalo, New York, United States, 14203
        • State University of New York, Buffalo
      • Flushing, New York, United States, 11355
        • New York Presbyterian Queens
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center
      • Columbus, Ohio, United States, 43214
        • OhioHealth Riverside Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Geisinger Health System
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center (UPMC)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80 years
  • Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Surgical Hematoma Evacuation
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Procedure: Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
No Intervention: Medical Management
Subjects will receive standard of care medical management for ICH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Improvement - mRS
Time Frame: 180 days
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Procedure-Related Mortality
Time Frame: 30 days
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
30 days
Safety - Hemorrhage Volume
Time Frame: 24 hours
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
24 hours
Economic
Time Frame: 30, 90, 120, and 180 days
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS
30, 90, 120, and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nico Corporation

Collaborators

Emory University

Investigators

  • Principal Investigator: Daniel Barrow, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
  • Principal Investigator: Gustavo Pradilla, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
  • Principal Investigator: Jonathan Ratcliff, MD, MPH, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC-6010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Hemorrhage

Clinical Trials on Early Surgical Hematoma Evacuation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe