ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH) (ENRICH)
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|ClinicalTrials.gov Identifier: NCT02880878|
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage||Procedure: Early Surgical Hematoma Evacuation||Not Applicable|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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).|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Early Surgical Hematoma Evacuation
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Procedure: Early Surgical Hematoma Evacuation
Early Minimally Invasive Parafascicular Surgery (MIPS)
No Intervention: Medical Management
Subjects will receive standard of care medical management for ICH.
- Functional Improvement - mRS [ Time Frame: 180 days ]Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days
- Safety - Procedure-Related Mortality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30, 90, 120, and 180 days ]Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY) gained through MIPS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880878
|Contact: Penny Sekerak, MBA, BA, RN||317-660-7118 ext 110||Penny.Sekerak@niconeuro.com|
|Contact: Sean Spence||317-660-7118 ext 115||Sean.Spence@niconeuro.com|
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|Principal Investigator:||Gustavo Pradilla, MD||1-877-572-5511 | email@example.com | Emory University School of Medicine|