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

Intracerebral Hemorrhage Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880878
• Other study ID #: DC-6010
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: February 2023

Study information

• Verified date: May 2023
• Source: Nico Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Haemorrhage
• Intracerebral Hemorrhage

Intervention

Procedure:
• Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore	Bronx	New York
United States	State University of New York, Buffalo	Buffalo	New York
United States	Cooper University Health Care	Camden	New Jersey
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
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	Geisinger Health System	Danville	Pennsylvania
United States	Delray Medical Center	Delray Beach	Florida
United States	NorthShore University Health System	Evanston	Illinois
United States	New York Presbyterian Queens	Flushing	New York
United States	Spectrum Health	Grand Rapids	Michigan
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University	Indianapolis	Indiana
United States	St. Vincent Indianapolis	Indianapolis	Indiana
United States	Baptist Health Jacksonville	Jacksonville	Florida
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California (USC)	Los Angeles	California
United States	University of Miami / Jackson Memorial Hospital	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Weill Cornell Medicine	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Barrow Neurological Institute (BNI)	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	Saint Louis University	Saint Louis	Missouri
United States	Washington University (Barnes Jewish)	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Nico Corporation	Emory University

Country where clinical trial is conducted

United States, 

References & Publications (21)

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 (Hagerstown). 2017 Feb 1;13(1):69-76. doi: 10.1227/NEU.0000000000001258. — View Citation

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.

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. — View Citation

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.

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.

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. — View 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. — View 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. — View Citation

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.

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.

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.

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.

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, 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.

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.

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. — View 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. — View 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. — View 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. — View Citation

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.

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Improvement - mRS	Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days	180 days
Secondary	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	30 days
Secondary	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	24 hours
Secondary	Economic	Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS	30, 90, 120, and 180 days

External Links

•   ENRICH Trial Website