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