ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
NCT ID: NCT02880878
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-12-31
2023-02-28
Brief Summary
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Detailed Description
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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, [email protected]
Sponsor - Backup: Jennifer Carroll, (317) 709-2466, [email protected]
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early Surgical Hematoma Evacuation
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
Medical Management
Subjects will receive standard of care medical management for ICH.
No interventions assigned to this group
Interventions
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Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Emory University
OTHER
Nico Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Barrow, MD
Role: PRINCIPAL_INVESTIGATOR
1-877-572-5511 | [email protected] | Emory University School of Medicine
Gustavo Pradilla, MD
Role: PRINCIPAL_INVESTIGATOR
1-877-572-5511 | [email protected] | Emory University School of Medicine
Jonathan Ratcliff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
1-877-572-5511 | [email protected] | Emory University School of Medicine
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute (BNI)
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Delray Medical Center
Delray Beach, Florida, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami / Jackson Memorial Hospital
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Vincent Indianapolis
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
Saint Louis University
St Louis, Missouri, United States
Washington University (Barnes Jewish)
St Louis, Missouri, United States
Cooper University Health Care
Camden, New Jersey, United States
Albany Medical Center
Albany, New York, United States
State University of New York, Buffalo
Buffalo, New York, United States
New York Presbyterian Queens
Flushing, New York, United States
Weill Cornell Medicine
New York, New York, United States
Montefiore
The Bronx, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Geisinger Health System
Danville, Pennsylvania, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
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.
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.
Bauer AM, Rasmussen PA, Bain MD. Initial Single-Center Technical Experience With the BrainPath System for Acute Intracerebral Hemorrhage Evacuation. Oper Neurosurg. 2017 Feb 1;13(1):69-76. doi: 10.1227/NEU.0000000000001258.
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.
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.
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.
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.
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.
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.
Kassam AB, Labib MA, Bafaquh M, et al. Part I: the challenge of functional preservation: an integrated systems approach using diffusion-weighted, image-guided, Exoscopic-assisted, transulcal radial corridors. Innovative Neurosurgy. 2015; 3(1-2): 5-23.
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.
Zucker, L. Corticospinal tract restoration post parafascicular transulcal subcortical (thalamic) ICH evacuation. Poster #1450 presented at: 2016 Congress of Neurological Surgeons Annual Meeting; September 24-28, 2016; San Diego, CA.
Chen J, Tran K, Dastur C, Stradling D, Yu W. The use of the BrainPath stereotactic guided surgery for the removal of spontaneous intracerebral hemorrhage: a single institutional experience. Abstract presented at: 2015 NeuroCritical Care Society Meeting; October 7-10, 2015; Scottsdale, AZ.
Kulwin C, Rodgers R, Shah M. Preliminary experience with evacuation of intracerebral hemorrhage via a minimally invasive parafascicular technique. Presented at: 2015 Neurosurgical Society of America Annual Meeting; April 2015.
Chen J, Kaloostian SW. Use of minimally invasive techniques under austere circumstances for the urgent resection of subcortical intracerebral hemorrhages. Poster #0075 presented at: 12th Annual Conference of the Society for Brain Mapping and Therapeutics; March 6-8, 2015.
Britz G, Kassam AB, Labib M, Young R, Zucker L, Maioriello A, et al. Minimally invasive subcortical parafascicular access for clot evacuation: a paradigm shift. Poster # MP120 presented at: 2015 International Stroke Conference; February 11-13, 2015; Nashville, TN.
Labib M, Britz G, Young R, Zucker L, Shah M, Kulwin CG, et al. The safety and efficacy of image-guided trans-sulcal radial corridors for hematoma evacuation: a multicenter study. Late breaking oral presentation LB12 at: 2015 International Stroke Conference; February 11-13, 2015; Nashville, TN.
Kulwin CG, Shah MV. Minimally invasive parafascicular approach to deep cerebral lesions: initial Indiana University experience. Presented at: 2014 Neurosurgical Society of America Annual Meeting; June 2014.
Labib M, Ghinda D, Bafaquh M, Kumar R, Agbi C, Kassam AB. The diffusion tensor imaging (DTI) guided Transulcul Exoscopic radial corridor approach for the resection of lesions in the sensorimotor area. Poster #1598 presented at: 2013 Congress of Neurological Surgeons Annual Meeting; October 19-23, 2013; San Francisco, CA.
Ghinda DC, Bafaquh M, Labib M, Kumar R, Agbi CB, Kassam AB. A Transulcul Exoscopic radial corridor approach for the management of primary intracranial hemorrhage. Poster #1621 presented at: 2013 Congress of Neurological Surgeons Annual Meeting; October 19-23, 2013; San Francisco, CA.
Hanmer J, Arnold J, Hall A, Ratcliff JJ, Allen JW, Frankel M, Wright DW, Barrow DL, Pradilla G, Smith KJ; ENRICH Trial Investigators. Cost-Effectiveness Analysis of Early Minimally Invasive Removal of Intracerebral Hemorrhage. Stroke. 2025 Jul;56(7):1799-1806. doi: 10.1161/STROKEAHA.124.048493. Epub 2025 Apr 25.
Pradilla G, Ratcliff JJ, Hall AJ, Saville BR, Allen JW, Paulon G, McGlothlin A, Lewis RJ, Fitzgerald M, Caveney AF, Li XT, Bain M, Gomes J, Jankowitz B, Zenonos G, Molyneaux BJ, Davies J, Siddiqui A, Chicoine MR, Keyrouz SG, Grossberg JA, Shah MV, Singh R, Bohnstedt BN, Frankel M, Wright DW, Barrow DL; ENRICH trial investigators; ENRICH Trial Investigators. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.
Ratcliff JJ, Hall AJ, Porto E, Saville BR, Lewis RJ, Allen JW, Frankel M, Wright DW, Barrow DL, Pradilla G. Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH): Study protocol for a multi-centered two-arm randomized adaptive trial. Front Neurol. 2023 Mar 16;14:1126958. doi: 10.3389/fneur.2023.1126958. eCollection 2023.
Related Links
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ENRICH Trial Website
Other Identifiers
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DC-6010
Identifier Type: -
Identifier Source: org_study_id
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