Enrollment

275 Enrolled Subjects                     300 Target Enrollment

ENRICH is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early surgical hematoma evacuation (less than 24 hours) using minimally invasive parafascicular surgery (MIPS) in the treatment of intracerebral hemorrhage (ICH), the deadliest, most costly and debilitating form of stroke worldwide. The acronym ENRICH means: Early MiNimally-invasive Removal of ICH.

The Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital leads the trial and it is sponsored by NICO Corporation. The ENRICH trial compares 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 all through a smaller opening than traditional surgery. 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). 

ICH is a major cause of morbidity and mortality and treatment of this disease remains a challenge for physicians, but improvement in critical care medicine, imaging technology, and surgical techniques have modestly improved patient survival.  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 (Bain 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.  ENRICH aims to contribute to the advancement and understanding of intracerebral hemorrhage care. 

What Clinicians Should Know About Adaptive Clinical Trials:

Intracerebral hemorrhage (ICH) is a type of stroke caused by bleeding within the brain tissue.  The most common type of ICH happens when a blood vessel inside the brain bursts and blood leaks into the surrounding brain tissue. It is considered the deadliest class of stroke because blood that accumulates within the brain after the rupture is toxic and more patients die from ICH than from any other form of stroke.

The most common cause of ICH is high blood pressure (hypertension). Other causes include trauma, tumors and abnormalities in blood vessels. Symptoms of ICH can include trouble with speaking and understanding, paralysis or numbness in the face, arms or legs, trouble with seeing in one or both eyes, severe headache, vomiting, dizziness, loss of balance or loss of coordination. 

During an ICH, blood collects in the brain tissue. As blood spills into the brain, the area of the brain attached is injured and this results in brain swelling that puts pressure on the rest of the brain.  If the blood is not removed, the toxins released by the blood clot produce even more brain swelling that can result in further brain injury, coma, and even death. 

Brain tissue is rapidly lost as a stroke progresses and emergency care and teatment are required. Once the cause and location of the bleeding is identified, treatment focuses on stopping the bleeding, removing the blood clot, and relieving the pressure on the brain. 

Studies show that early removal of the blood could potentially stop or significantly slow down brain injury.

Economic Outcomes Team

xx

x