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.
Brief Title
ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)
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
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Intracerebral Hemorrhage
Cerebral Hemorrhage
Intracerebral Haemorrhage
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT02880878
Org Class
Industry
Org Full Name
Nico Corporation
Org Study Id
DC-6010
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
ENRICH: 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).
Primary Outcomes
Outcome Description
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
Outcome Measure
Functional Improvement - mRS
Outcome Time Frame
180 days
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
30 days
Outcome Measure
Safety - Procedure-Related Mortality
Outcome Description
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
Outcome Time Frame
24 hours
Outcome Measure
Safety - Hemorrhage Volume
Outcome Description
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS
Outcome Time Frame
30, 90, 120, and 180 days
Outcome Measure
Economic
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498