Clinical Trial TitleENRICH: 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).
Clinical Trial Protocol 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).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are between 18-80 years of age.
- Have had a pre-randomization head CT demonstrating an acute, spontaneous, primary ICH.
- Have a 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
You will be excluded from the study if any of the following criteria apply to you:
- Have a 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.
- Have an NIHSS < 5.
- Have bilateral fixed dilated pupils.
- Have extensor motor posturing.
This is a partial list of inclusion and exclusion criteria.