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

NICO Corporation

Status: Completed

Conditions: Intracerebral Haemorrhage; Cerebral Hemorrhage; Intracerebral Hemorrhage

Treatments: Procedure: Early Surgical Hematoma Evacuation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02880878

DC-6010

Details and patient eligibility

About

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.

Full 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 [phone], [e-mail]

Sponsor - Backup: Jennifer Carroll, [phone], [e-mail]

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Early Surgical Hematoma Evacuation

Experimental group

Description:

Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).

Treatment:

Procedure: Early Surgical Hematoma Evacuation

Medical Management

No Intervention group

Description:

Subjects will receive standard of care medical management for ICH.