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

Primary Purpose

Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Surgical Hematoma Evacuation
Sponsored by
Nico Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Subcortical Intracerebral Hemorrhage, Intracerebral Hemorrhage, Intracranial Hemorrhages, ICH, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Pathologic Processes, MIPS, Minimally Invasive Parafascicular Surgery, Neurosurgery, Medical Economic, Hospital Economics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Barrow Neurological Institute (BNI)
  • University of Arkansas for Medical Sciences
  • University of Southern California (USC)
  • Cedars-Sinai Medical Center
  • Delray Medical Center
  • Baptist Health Jacksonville
  • Mayo Clinic
  • University of Miami / Jackson Memorial Hospital
  • Emory University School of Medicine
  • Rush University Medical Center
  • NorthShore University Health System
  • OSF Saint Francis Medical Center
  • Indiana University
  • St. Vincent Indianapolis
  • Johns Hopkins University
  • Brigham and Women's Hospital
  • Spectrum Health
  • Saint Louis University
  • Washington University (Barnes Jewish)
  • Cooper University Health Care
  • Albany Medical Center
  • Montefiore
  • State University of New York, Buffalo
  • New York Presbyterian Queens
  • Weill Cornell Medicine
  • The University of North Carolina at Chapel Hill
  • Cleveland Clinic Foundation
  • Ohio State University Wexner Medical Center
  • OhioHealth Riverside Methodist Hospital
  • University of Oklahoma
  • Geisinger Health System
  • Penn State Hershey Medical Center
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center (UPMC)
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Surgical Hematoma Evacuation

Medical Management

Arm Description

Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).

Subjects will receive standard of care medical management for ICH.

Outcomes

Primary Outcome Measures

Functional Improvement - mRS
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days

Secondary Outcome Measures

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
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
Economic
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS

Full Information

First Posted
August 18, 2016
Last Updated
May 8, 2023
Sponsor
Nico Corporation
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02880878
Brief Title
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
Acronym
ENRICH
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 2022 (Actual)
Study Completion Date
February 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nico Corporation
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage
Keywords
Subcortical Intracerebral Hemorrhage, Intracerebral Hemorrhage, Intracranial Hemorrhages, ICH, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Pathologic Processes, MIPS, Minimally Invasive Parafascicular Surgery, Neurosurgery, Medical Economic, Hospital Economics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Surgical Hematoma Evacuation
Arm Type
Experimental
Arm Description
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Arm Title
Medical Management
Arm Type
No Intervention
Arm Description
Subjects will receive standard of care medical management for ICH.
Intervention Type
Procedure
Intervention Name(s)
Early Surgical Hematoma Evacuation
Intervention Description
Early Minimally Invasive Parafascicular Surgery (MIPS)
Primary Outcome Measure Information:
Title
Functional Improvement - mRS
Description
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Safety - Procedure-Related Mortality
Description
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
Time Frame
30 days
Title
Safety - Hemorrhage Volume
Description
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
Time Frame
24 hours
Title
Economic
Description
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS
Time Frame
30, 90, 120, and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Barrow, MD
Organizational Affiliation
1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Pradilla, MD
Organizational Affiliation
1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Ratcliff, MD, MPH
Organizational Affiliation
1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Barrow Neurological Institute (BNI)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Southern California (USC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Delray Medical Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Baptist Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami / Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
St. Vincent Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University (Barnes Jewish)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper University Health Care
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
State University of New York, Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
New York Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27322807
Citation
Labib MA, Shah M, Kassam AB, Young R, Zucker L, Maioriello A, Britz G, Agbi C, Day JD, Gallia G, Kerr R, Pradilla G, Rovin R, Kulwin C, Bailes J. The Safety and Feasibility of Image-Guided BrainPath-Mediated Transsulcul Hematoma Evacuation: A Multicenter Study. Neurosurgery. 2017 Apr 1;80(4):515-524. doi: 10.1227/NEU.0000000000001316.
Results Reference
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PubMed Identifier
27195160
Citation
Chen CJ, Caruso J, Starke RM, Ding D, Buell T, Crowley RW, Liu KC. Endoport-Assisted Microsurgical Treatment of a Ruptured Periventricular Aneurysm. Case Rep Neurol Med. 2016;2016:8654262. doi: 10.1155/2016/8654262. Epub 2016 Apr 19.
Results Reference
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Amenta PS, Dumont AS, Medel R. Resection of a left posterolateral thalamic cavernoma with the Nico BrainPath sheath: case report, technical note, and review of the literature. Interdisciplinary Neurosurgery: Advanced Techniques and Case Management. 2016; 5:12-17.
Results Reference
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PubMed Identifier
28931255
Citation
Bauer AM, Rasmussen PA, Bain MD. Initial Single-Center Technical Experience With the BrainPath System for Acute Intracerebral Hemorrhage Evacuation. Oper Neurosurg (Hagerstown). 2017 Feb 1;13(1):69-76. doi: 10.1227/NEU.0000000000001258.
Results Reference
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PubMed Identifier
27214701
Citation
Ziai W, Nyquist P, Hanley DF. Surgical Strategies for Spontaneous Intracerebral Hemorrhage. Semin Neurol. 2016 Jun;36(3):261-8. doi: 10.1055/s-0036-1582131. Epub 2016 May 23.
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PubMed Identifier
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Citation
Fiorella D, Arthur A, Bain M, Mocco J. Minimally Invasive Surgery for Intracerebral and Intraventricular Hemorrhage: Rationale, Review of Existing Data and Emerging Technologies. Stroke. 2016 May;47(5):1399-406. doi: 10.1161/STROKEAHA.115.011415. Epub 2016 Apr 5. No abstract available. Erratum In: Stroke. 2016 May;47(5):e91.
Results Reference
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PubMed Identifier
26463961
Citation
Chen JW, Paff MR, Abrams-Alexandru D, Kaloostian SW. Decreasing the Cerebral Edema Associated with Traumatic Intracerebral Hemorrhages: Use of a Minimally Invasive Technique. Acta Neurochir Suppl. 2016;121:279-84. doi: 10.1007/978-3-319-18497-5_48.
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PubMed Identifier
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Citation
Przybylowski CJ, Ding D, Starke RM, Webster Crowley R, Liu KC. Endoport-assisted surgery for the management of spontaneous intracerebral hemorrhage. J Clin Neurosci. 2015 Nov;22(11):1727-32. doi: 10.1016/j.jocn.2015.05.015. Epub 2015 Jul 31.
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26142050
Citation
Ding D, Przybylowski CJ, Starke RM, Sterling Street R, Tyree AE, Webster Crowley R, Liu KC. A minimally invasive anterior skull base approach for evacuation of a basal ganglia hemorrhage. J Clin Neurosci. 2015 Nov;22(11):1816-9. doi: 10.1016/j.jocn.2015.03.052. Epub 2015 Jun 30.
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Kassam AB, Labib MA, Bafaquh M, et al. Part II: an evaluation of an integrated systems approach using diffusion-weighted, image-guided, Exoscopic-assisted, transulcal radial corridors. Innovative Neurosurg. 2015; 3(1-2): 25-33.
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PubMed Identifier
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Citation
Ritsma B, Kassam A, Dowlatshahi D, Nguyen T, Stotts G. Minimally Invasive Subcortical Parafascicular Transsulcal Access for Clot Evacuation (Mi SPACE) for Intracerebral Hemorrhage. Case Rep Neurol Med. 2014;2014:102307. doi: 10.1155/2014/102307. Epub 2014 Aug 6.
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Links:
URL
http://www.enrichtrial.com
Description
ENRICH Trial Website

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

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