ENRICH Goal

The purpose of the ENRICH trial is to provide clinical evidence of functional improvement, safety and economic benefit, measured by various endpoints, when comparing early surgical evacuation to the standard of care medical management for ICH.   

The ENRICH trial began in December 2016 and will include at least 15 centers. The estimated primary completion date is December 2019, with final data collection completed for primary outcome measurement. Full study completion is expected in July 2020. Patient enrollment of 300 is estimated to take one year, with six months for patient follow up. Ideal trial candidates are spontaneous supratentorial ICH patients with a good clinical chance of benefiting from the surgical treatment based on well-defined criteria for study enrollment.

The trial will build on current peer-reviewed clinical data on the BrainPath Approach including a preliminary series of 39 patients treated for supratentorial spontaneous ICH.  A 2016 Neurosurgery publication retrospectively reviewed patients from 11 centers and reported on the safety and feasibility of hematoma evacuation using a trans-sulcal surgical approach with BrainPath (1).  Results showed greater than or equal to 90%, 75%, and 50% degree of hematoma evacuation in 72%, 23%, and 5% of patients, respectively, as well as no new surgical deficits or mortalities.  Additionally, “statistically significant” improvement in patients’ neurological state was associated with early intervention.  The publication was cited as a breakthrough in the treatment of hemorrhagic stroke by the National Stroke Association.  

These results were replicated in an independent single-center study conducted by the Cleveland Clinic Foundation in 18 patients and published in Operative Neurosurgery in 2016 (2).  The authors at Cleveland Clinic reported mean clot volume reduction of 95.7% and a median GCS improvement from 10 to 14.  In addition, the bleeding source was identified in 65% of patients and coagulated with no rebleeds resulting during follow-up.    

The trial will allow centers to produce prospective data documenting the best course of action for patients who are treated for this very deadly form of stroke.

 

1. Labib MA, Shah M, Kassam AB, Young R, Zucker L, Maioriello A, et al.  The safety and feasibility of image-guided BrainPath-mediated transsulcul hematoma evacuation: a multicenter study.  Neurosurgery.  2016: Published online AOP, June 17, 2016.  

2. Bauer AM, Rasmussen PA, Bain MD.  Initial single-center technical experience with the BrainPath system for acute intracerebral hemorrhage evacuation.  Operative Neurosurgery.  2016; 0:1-7.  

ENRICH Criteria

Inclusion Criteria

  • Age 18-80 years
  • Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
  • Manual ICH volume between 30-80mL
  • 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 (less than 1 year) ICH, as diagnosed with radiographic imaging
  • NIHSS less than 5
  • Bilateral fixed dilated pupils
  • Extensor motor posturing
  • Intraventricular extension of the hemorrhage is visually estimated to involve greater than 50 percent 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 less than 75,000, International Normalized Ratio (INR) greater than 1.4 after correction
  • Patients requiring long-term anti-coagulation that needs to be initiated less than 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