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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2023 by Nico Corporation
Sponsor
Nico Corporation
Information Provided by (Responsible Party)
Nico Corporation
Clinicaltrials.gov Identifier
NCT02880878
Other Study ID Numbers:
DC-6010
First Submitted
August 17, 2016
First Posted
August 25, 2016
Last Update Posted
May 9, 2023
Last Verified
April 2023

ClinicalTrials.gov processed this data on May 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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 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

Condition or DiseaseIntervention/Treatment
Intracerebral HemorrhageCerebral HemorrhageIntracerebral Haemorrhage
Procedure: Early Surgical Hematoma Evacuation

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleENRICH: 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).
Study Start DateNovember 30, 2016
Actual Primary Completion DateJuly 31, 2022
Actual Study Completion DateJanuary 31, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
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)
Medical Management
Subjects will receive standard of care medical management for ICH.

Outcome Measures

Primary Outcome Measures
  1. Functional Improvement - mRS
    Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
Secondary Outcome Measures
  1. 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
  2. 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
  3. Economic
    Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsNico Corporation
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35294Barrow Neurological Institute (BNI) | Phoenix Arizona, United States, 85013University of Arkansas for Medical Sciences | Little Rock Arkansas, United States, 72205University of Southern California (USC) | Los Angeles California, United States, 90033Cedars-Sinai Medical Center | Los Angeles California, United States, 90048Delray Medical Center | Delray Beach Florida, United States, 33484Baptist Health Jacksonville | Jacksonville Florida, United States, 32207Mayo Clinic | Jacksonville Florida, United States, 32224University of Miami / Jackson Memorial Hospital | Miami Florida, United States, 33136Emory University School of Medicine | Atlanta Georgia, United States, 30303Rush University Medical Center | Chicago Illinois, United States, 60612NorthShore University Health System | Evanston Illinois, United States, 60201OSF Saint Francis Medical Center | Peoria Illinois, United States, 61637Indiana University | Indianapolis Indiana, United States, 46202St. Vincent Indianapolis | Indianapolis Indiana, United States, 46260Johns Hopkins University | Baltimore Maryland, United States, 21287Brigham and Women's Hospital | Boston Massachusetts, United States, 02115Spectrum Health | Grand Rapids Michigan, United States, 49503Saint Louis University | St Louis Missouri, United States, 63110Washington University (Barnes Jewish) | St Louis Missouri, United States, 63110Cooper University Health Care | Camden New Jersey, United States, 08103Albany Medical Center | Albany New York, United States, 12208State University of New York, Buffalo | Buffalo New York, United States, 14203New York Presbyterian Queens | Flushing New York, United States, 11355Weill Cornell Medicine | New York New York, United States, 10021Montefiore | The Bronx New York, United States, 10467The University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27599Cleveland Clinic Foundation | Cleveland Ohio, United States, 44195Ohio State University Wexner Medical Center | Columbus Ohio, United States, 43210OhioHealth Riverside Methodist Hospital | Columbus Ohio, United States, 43214University of Oklahoma | Oklahoma City Oklahoma, United States, 73104Geisinger Health System | Danville Pennsylvania, United States, 17821Penn State Hershey Medical Center | Hershey Pennsylvania, United States, 17033Allegheny General Hospital | Pittsburgh Pennsylvania, United States, 15212University of Pittsburgh Medical Center (UPMC) | Pittsburgh Pennsylvania, United States, 15213Vanderbilt University Medical Center | Nashville Tennessee, United States, 37232
Investigators
Principal Investigator: Daniel Barrow, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of MedicinePrincipal Investigator: Gustavo Pradilla, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of MedicinePrincipal Investigator: Jonathan Ratcliff, MD, MPH, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine