Cerebral Hemorrhage, Intracerebral Haemorrhage, Intracerebral Hemorrhage
Conditions
Keywords
Subcortical Intracerebral Hemorrhage, Intracerebral Hemorrhage, Intracranial Hemorrhages, ICH, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Pathologic Processes, MIPS, Minimally Invasive Parafascicular Surgery, Neurosurgery, Medical Economic, Hospital Economics
Brief summary
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.
Detailed 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 (317) 569-1229, Penny.Sekerak@niconeuro.com Sponsor - Backup: Jennifer Carroll, (317) 709-2466, Jennifer.Carroll@niconeuro.com
Interventions
PROCEDUREEarly Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
Sponsors
Emory University
Nico Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement - mRS | 180 days | Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Procedure-Related Mortality | 30 days | Safety will be assessed by determining procedure-related mortality by comparing rates of mortality at 30 days for patients that underwent MIPS with medically treated patients |
| Safety - Hemorrhage Volume | 24 hours | Safety will be assessed by evaluating whether MIPS does not result in an increase in hemorrhage volume between index CT and 24-hour follow-up CT as compared to medically treated patients |
| Economic | 30, 90, 120, and 180 days | Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS |
Countries
United States
Outcome results
None listed