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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Nico Corporation
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Nico Corporation
ClinicalTrials.gov Identifier:
NCT02880878
First received: August 18, 2016
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
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 Intervention
Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage Procedure: Early Surgical Hematoma Evacuation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Nico Corporation:

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

Secondary Outcome Measures:
  • 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 [ Time Frame: 30 days ]
  • Safety will be assessed by evaluating whether MIPS does not result in an increase in change of hemorrhage volume between index CT and 24-hour follow-up CT as compared to medically treated patients [ Time Frame: 24 hours ]
  • Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS [ Time Frame: 30, 90, 120, and 180 days ]

Estimated Enrollment: 300
Study Start Date: December 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 a 10% 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  • Manual 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880878

Contacts
Contact: Penny Sekerak, MBA, BA, RN 317-660-7118 ext 110 Penny.Sekerak@niconeuro.com
Contact: Sean Spence 317-660-7118 ext 115 Sean.Spence@niconeuro.com

Locations
United States, California
University of Southern California (USC) Recruiting
Los Angeles, California, United States, 90033
Contact: Anush Arakelyan, MPH, CCRP    323-442-7544    Anush.Arakelyan@med.usc.edu   
Principal Investigator: Gabriel Zada, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Vicki Manoukian, MA    310-423-5067    vicki.manoukian@cshs.org   
Principal Investigator: Michael Alexander, MD         
United States, Georgia
Emory University School of Medicine - Primary Site & Scientific Leadership Team Recruiting
Atlanta, Georgia, United States, 30303
Contact: Gustavo Pradilla, MD    877-572-5511    ENRICH@emory.edu   
Contact: Alex Hall, MS, RN    1-877-572-5511    ENRICH@emory.edu   
Principal Investigator: Gustavo Pradilla, MD         
Principal Investigator: Jonathan Ratcliff, MD, MPH         
Principal Investigator: Daniel Barrow, MD         
Sub-Investigator: Victoria Phillips, PhD         
Sub-Investigator: Michael Frankel, MD         
Sub-Investigator: David Wright, MD         
Sub-Investigator: Jason Allen, MD, PhD         
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Boris Jancan, MD, CCRP    847-570-4224    bjancan@northshore.org   
Contact: Robert Frech, BS, CCRP    847-570-4224    rfrech@northshore.org   
Principal Investigator: Shakeel Chowdhry, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lauren Snyder, RN    317-396-1254    lmillar@iu.edu   
Contact: Heather Cero, RN    317-396-1298    hcero@iupui.edu   
Principal Investigator: Mitesh Shah, MD         
United States, Missouri
Washington University (Barnes Jewish) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: John Evans, RN, CCRC    314-362-3473    evansj@wudosis.wustl.edu   
Principal Investigator: Michael Chicoine, MD         
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Anne Beckwith, BS, CCRP    919-843-8797    beckwitha@neurology.unc.edu   
Principal Investigator: Deanna Sasaki-Adams, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Vikram Puvenna    216-444-3120    puvennv@ccf.org   
Contact: Mark Bain, MD    216-445-6575    bainm@ccf.org   
Principal Investigator: Mark Bain, MD         
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Blair Apple, BS    405-271-4658    Blair-Apple@ouhsc.edu   
Contact: Brittany Karfonta, BS    405-27104658    Brittany-Karfonta@ouhsc.edu   
Principal Investigator: Bradley Bohnstedt, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lisa Baxendell    412-605-3959    baxelx@upmc.edu   
Contact: Patricia Feineigle    412-647-4992    feineiglepa3@upmc.edu   
Principal Investigator: Brian Jankowitz, MD         
Sponsors and Collaborators
Nico Corporation
Emory University
Investigators
Principal Investigator: Gustavo Pradilla, MD 1-877-572-5511 | gpradil@emory.edu | Emory University School of Medicine
  More Information

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.
Bauer AM, Rasmussen PA, Bain MD. Initial single-center technical experience with the BrainPath system for acute intracerebral hemorrhage evacuation. Operative Neurosurgery. 2016; 0:1-7.
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.

Responsible Party: Nico Corporation
ClinicalTrials.gov Identifier: NCT02880878     History of Changes
Other Study ID Numbers: DC-6010
Study First Received: August 18, 2016
Last Updated: May 19, 2017
Individual Participant Data  
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:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 27, 2017