ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

Sponsor

Nico Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02880878

Collaborator

Emory University (Other)

300

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage Cerebral Hemorrhage Intracerebral Haemorrhage	Procedure: Early Surgical Hematoma Evacuation	N/A

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 :

Dec 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Functional Improvement - mRS [180 days]
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180-days

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-80 years
Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
Manual 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Barrow Neurological Institute (BNI)	Phoenix	Arizona	United States	85013
3	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	University of Southern California (USC)	Los Angeles	California	United States	90033
5	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
6	Delray Medical Center	Delray Beach	Florida	United States	33484
7	Baptist Health Jacksonville	Jacksonville	Florida	United States	32207
8	Mayo Clinic	Jacksonville	Florida	United States	32224
9	University of Miami / Jackson Memorial Hospital	Miami	Florida	United States	33136
10	Emory University School of Medicine	Atlanta	Georgia	United States	30303
11	Rush University Medical Center	Chicago	Illinois	United States	60612
12	NorthShore University Health System	Evanston	Illinois	United States	60201
13	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
14	Indiana University	Indianapolis	Indiana	United States	46202
15	St. Vincent Indianapolis	Indianapolis	Indiana	United States	46260
16	Johns Hopkins University	Baltimore	Maryland	United States	21287
17	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
18	Spectrum Health	Grand Rapids	Michigan	United States	49503
19	Saint Louis University	Saint Louis	Missouri	United States	63110
20	Washington University (Barnes Jewish)	Saint Louis	Missouri	United States	63110
21	Cooper University Health Care	Camden	New Jersey	United States	08103
22	Albany Medical Center	Albany	New York	United States	12208
23	Montefiore	Bronx	New York	United States	10467
24	State University of New York, Buffalo	Buffalo	New York	United States	14203
25	New York Presbyterian Queens	Flushing	New York	United States	11355
26	Weill Cornell Medicine	New York	New York	United States	10021
27	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
28	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
29	Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
30	OhioHealth Riverside Methodist Hospital	Columbus	Ohio	United States	43214
31	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
32	Geisinger Health System	Danville	Pennsylvania	United States	17821
33	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
34	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
35	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania	United States	15213
36	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Nico Corporation
Emory University

Investigators

Principal Investigator: Daniel Barrow, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
Principal Investigator: Gustavo Pradilla, MD, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine
Principal Investigator: Jonathan Ratcliff, MD, MPH, 1-877-572-5511 | ENRICH@emory.edu | Emory University School of Medicine