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Intracerebral HemorrhageENRICHNCT02880878

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

A study testing Early Surgical Hematoma Evacuation in people with Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Nico Corporation at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Early Surgical Hematoma Evacuation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
36 sitesUnited States
Study dates
Dec 2016to Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Emory University School of Medicine

    Atlanta, Georgia, 30303

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • State University of New York, Buffalo

    Buffalo, New York, 14203

  • Cooper University Health Care

    Camden, New Jersey, 08103

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Geisinger Health System

    Danville, Pennsylvania, 17821

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • New York Presbyterian Queens

    Flushing, New York, 11355

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Indiana University

    Indianapolis, Indiana, 46202

  • St. Vincent Indianapolis

    Indianapolis, Indiana, 46260

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • University of Southern California (USC)

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Miami / Jackson Memorial Hospital

    Miami, Florida, 33136

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medicine

    New York, New York, 10021

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Barrow Neurological Institute (BNI)

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213

  • Saint Louis University

    St Louis, Missouri, 63110

  • Washington University (Barnes Jewish)

    St Louis, Missouri, 63110

  • Montefiore

    The Bronx, New York, 10467

Other trials in United States

About this study

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).

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.

Read the 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

Being tested
Early Surgical Hematoma Evacuation
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
Medical subject headings
Cerebral Hemorrhage, Intracranial Hemorrhages, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Surgical Hematoma EvacuationProcedure or surgery

    Early Minimally Invasive Parafascicular Surgery (MIPS)

Study groups in NCT02880878
Study groupRoleWhat they receive
Early Surgical Hematoma EvacuationExperimentalSubjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Receives: Procedure: Early Surgical Hematoma Evacuation
Medical ManagementNo interventionSubjects will receive standard of care medical management for ICH.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Improvement - mRS

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

    Measured: 180 days

Secondary outcomes (3)

  1. 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

    Measured: 30 days

  2. 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

    Measured: 24 hours

  3. Economic

    Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS

    Measured: 30, 90, 120, and 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionAug 2022
  4. Study completionFeb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880878
Sponsor's protocol ID
DC-6010
Acronym
ENRICH
Status last verified
May 2023
First submitted
18 Aug 2016
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 27322807

  • 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.

    PubMed 27195160

  • 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. 2017 Feb 1;13(1):69-76. doi: 10.1227/NEU.0000000000001258.

    PubMed 28931255

  • 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.

    PubMed 27214701

  • 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.

    PubMed 27048700

  • 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.

    PubMed 26463961

  • 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.

    PubMed 26238692

  • 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.

    PubMed 26142050

  • 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.

  • 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.

    PubMed 25165588

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Early Surgical Hematoma Evacuation in people with Intracerebral Hemorrhage and Cerebral Hemorrhage, run by Nico Corporation at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Improvement - mRS (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880878, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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