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

Not Applicable

Completed

• Conditions: Intracerebral Hemorrhage; Cerebral Hemorrhage; Intracerebral Haemorrhage

• Registration Number: NCT02880878
• Lead Sponsor: Nico Corporation

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

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Study Start: 2016-12
• Primary Completion: 2022-08
• Study Completion: 2023-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety - Hemorrhage Volume	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
Safety - Procedure-Related Mortality	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
Economic	30, 90, 120, and 180 days	Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS

Trial Locations

Locations (36)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Barrow Neurological Institute (BNI); 🇺🇸 Phoenix, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

University of Southern California (USC); 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States

Baptist Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Miami / Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

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