Clinical trial NCT02880878: ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Nico Corporation
Sponsor class: INDUSTRY
Collaborators: name: Emory University
First posted: 2016-08-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Functional Improvement - mRS
timeFrame: 180 days
Secondary outcomes:
measure: Safety - Procedure-Related Mortality
timeFrame: 30 days
measure: Safety - Hemorrhage Volume
timeFrame: 24 hours
measure: Economic
timeFrame: 30, 90, 120, and 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute (BNI)
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami / Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Indianapolis
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University (Barnes Jewish)
state: Missouri
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore
state: New York
city: Buffalo
country: United States
facility: State University of New York, Buffalo
state: New York
city: Flushing
country: United States
facility: New York Presbyterian Queens
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
name: Daniel Barrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
name: Gustavo Pradilla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
name: Jonathan Ratcliff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
citation: 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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
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.