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

NCT02880878 | Completed DMC

• 1 other identifier: DC-6010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 36

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Functional Improvement - mRS

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

  180 days

Secondary Outcomes (3)

• Safety - Procedure-Related Mortality

  30 days

• Safety - Hemorrhage Volume

  24 hours

• Economic

  30, 90, 120, and 180 days

Study Arms (2)

Early Surgical Hematoma Evacuation

EXPERIMENTAL

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

Procedure: Early Surgical Hematoma Evacuation

Medical Management

NO INTERVENTION

Subjects will receive standard of care medical management for ICH.

Interventions

Early Surgical Hematoma Evacuation PROCEDURE

Early Minimally Invasive Parafascicular Surgery (MIPS)

Early Surgical Hematoma Evacuation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nico Corporation: lead
• Emory University: collaborator

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Barrow Neurological Institute (BNI)

Phoenix, Arizona, 85013, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Southern California (USC)

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami / Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Indianapolis

Indianapolis, Indiana, 46260, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Washington University (Barnes Jewish)

St Louis, Missouri, 63110, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York, Buffalo

Buffalo, New York, 14203, United States

Location

New York Presbyterian Queens

Flushing, New York, 11355, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17821, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (24)

• 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.

  PMID: 27322807 BACKGROUND

• 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.

  PMID: 27195160 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28931255 BACKGROUND

• 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.

  PMID: 27214701 BACKGROUND

• 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.

  PMID: 27048700 BACKGROUND

• 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.

  PMID: 26463961 BACKGROUND

• 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.

  PMID: 26238692 BACKGROUND

• 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.

  PMID: 26142050 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25165588 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 40276867 DERIVED

• 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.

  PMID: 38598795 DERIVED

• 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.

  PMID: 37006503 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Hemorrhage; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)