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

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ClinicalTrials.gov Identifier: NCT02880878
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : May 10, 2023
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Nico Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage Procedure: Early Surgical Hematoma Evacuation Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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).
Actual Study Start Date : December 2016
Actual Primary Completion Date : August 2022
Actual Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Early Surgical Hematoma Evacuation
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
 Procedure: Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
No Intervention: Medical Management
Subjects will receive standard of care medical management for ICH.


Outcome Measures
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Primary Outcome Measures :
  1. Functional Improvement - mRS [ Time Frame: 180 days ]
    Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days


Secondary Outcome Measures :
  1. Safety - Procedure-Related Mortality [ Time Frame: 30 days ]
    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

  2. Safety - Hemorrhage Volume [ Time Frame: 24 hours ]
    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

  3. Economic [ Time Frame: 30, 90, 120, and 180 days ]
    Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880878


Locations
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Sponsors and Collaborators
Nico Corporation
Emory University
Investigators
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Principal Investigator: 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
More Information
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Additional Information:

Publications:
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.
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.
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.

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Responsible Party: Nico Corporation
ClinicalTrials.gov Identifier: NCT02880878    
Other Study ID Numbers: DC-6010
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nico Corporation:
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
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases