Phase
Condition
Stroke
Hemorrhage
Brain Injury
Treatment
Best Medical Management Alone (MM)
Artemis + Medical Management
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient age ≥ 18 and ≤ 80
Supratentorial ICH of volume ≥ 20 and ≤ 80 cc (measured using A x B X C/2 method)
Hemostasis as confirmed by no arterial spot sign (may perform additional scan(s)every 6 hours to demonstrate hemostasis)
NIHSS ≥ 6
GCS ≥ 5 and ≤ 15
Historical mRS 0 or 1
Symptom onset < 24 hours prior to initial CT/MR
MIS must be initiated within 72 hours of ictus/bleed
SBP must be < 180 mmHg and controlled at this level for at least 6 hours
Exclusion
Exclusion Criteria:
Imaging
"Arterial Spot Sign" identified on final CTA indicating expanding hemorrhage
Hemorrhagic lesion such as a vascular malformation (cavernous malformation, AVMetc.), aneurysm, and/or neoplasm
Hemorrhagic conversion of an underlying ischemic stroke
Infratentorial hemorrhage
Primary thalamic ICH (where the center of the hemorrhage emulates from thethalamus)
Associated intra-ventricular hemorrhage requiring treatment for IVH-relatedmass effect or shift due to trapped ventricle (EVD for ICP management isallowed)
Midbrain extension/involvement
Absolute contraindication to CTA, conventional angiography and MRA
Coagulation Issues
Absolute requirement for long-term anti-coagulation (e.g., mechanical valvereplacement (bio-prostatic valve is permitted), high risk atrial fibrillation)
Known hereditary or acquired hemorrhagic diathesis, coagulation factordeficiency
Platelet count < 100 x 10^3 cells/mm3 or known platelet dysfunction
INR > 1.4, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupusanti-coagulant)
Use of direct factor Xa inhibitors (e.g. apixaban, rivaroxaban, fondaparinux)within last 48 hours
Patient Factors
Traumatic ICH
High risk atrial fibrillation (e.g., mitral stenosis with atrial fibrillation)and/or symptomatic carotid stenosis
Requirement for emergent surgical decompression or uncontrolled ICP after EVD
Unable to obtain consent per Institution Review Board/Ethics Committee policy
Pregnancy or positive pregnancy test (either serum or urine). Women ofchild-bearing potential must have a negative pregnancy test prior to enrollment
Severe active infection requiring treatment (e.g. sepsis or purulent wound) atthe time of enrollment
Renal failure indicated by creatinine > 2 mg/dL or undergoing dialysis
Any comorbid disease or condition expected to compromise survival or ability tocomplete follow-up assessments through 365 days
Based on investigator's judgement, patient is unwilling or unable to complywith protocol follow up appointment schedule
Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator would interfere with adherence to study requirements
Currently participating in another interventional (drug, device, etc) clinicaltrial. Patients in observational, natural history, and/or epidemiologicalstudies not involving intervention are eligible.
Study Design
Connect with a study center
Uniklinikum Salzburg
Salzburg,
AustriaSite Not Available
Uniklinikum Salzburg
Salzburg 2766824,
AustriaSite Not Available
University of Alberta
Edmonton, Alberta
CanadaSite Not Available
University of Alberta
Edmonton 5946768, Alberta 5883102
CanadaSite Not Available
Universitätsklinikum Augsburg
Augsburg,
GermanySite Not Available
Universitätsklinikum Augsburg
Augsburg 2954172,
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin,
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin 2950159,
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg im Breisgau,
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg im Breisgau 2925177,
GermanySite Not Available
München Klinik Bogenhausen
München,
GermanySite Not Available
München Klinik Bogenhausen
München 2867711,
GermanySite Not Available
Abrazo Central
Phoenix, Arizona 85015
United StatesSite Not Available
Abrazo Central
Phoenix 5308655, Arizona 5551752 85015
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
Mission Hospital
Mission Viejo, California 92691
United StatesSite Not Available
UCLA
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Mission Hospital
Mission Viejo 5373763, California 5332921 92691
United StatesSite Not Available
Swedish - HCA
Englewood, Colorado 80113
United StatesSite Not Available
Swedish - HCA
Englewood 5421250, Colorado 5417618 80113
United StatesSite Not Available
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Yale University
New Haven 4839366, Connecticut 4831725 06510
United StatesSite Not Available
Christiana Health
Newark, Delaware 19718
United StatesSite Not Available
Christiana Health
Newark 4143861, Delaware 4142224 19718
United StatesSite Not Available
George Washington
Washington, District of Columbia 20052
United StatesSite Not Available
George Washington
Washington D.C. 4140963, District of Columbia 4138106 20052
United StatesSite Not Available
Loyola University Chicago
Chicago, Illinois 60660
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesSite Not Available
Loyola University Chicago
Chicago 4887398, Illinois 4896861 60660
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40506
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40292
United StatesSite Not Available
University of Kentucky
Lexington 4297983, Kentucky 6254925 40506
United StatesSite Not Available
University of Louisville
Louisville 4299276, Kentucky 6254925 40292
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Medical Center
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
University of Mississippi
Jackson, Mississippi 39216
United StatesSite Not Available
University of Mississippi
Jackson 4431410, Mississippi 4436296 39216
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65211
United StatesSite Not Available
University of Missouri
Columbia 4381982, Missouri 4398678 65211
United StatesSite Not Available
Atlantic Neuroscience Institute
Summit, New Jersey 07901
United StatesSite Not Available
Atlantic Neuroscience Institute
Summit 5105127, New Jersey 5101760 07901
United StatesSite Not Available
Maimonides
Brooklyn, New York 11219
United StatesSite Not Available
Northwell Health
Manhasset, New York 11030
United StatesSite Not Available
Mount Sinai
New York, New York 10029
United StatesSite Not Available
Stony Brook University
Stony Brook, New York 11794
United StatesSite Not Available
Maimonides
Brooklyn 5110302, New York 5128638 11219
United StatesSite Not Available
Northwell Health
Manhasset 5125766, New York 5128638 11030
United StatesSite Not Available
Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Stony Brook University
Stony Brook 5139865, New York 5128638 11794
United StatesSite Not Available
Novant Health
Charlotte, North Carolina 28277
United StatesSite Not Available
Novant Health
Charlotte 4460243, North Carolina 4482348 28277
United StatesSite Not Available
University Hospital Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
University Hospital Cleveland
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
OUHSC
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
MUSC
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Methodist University Hospital
Memphis, Tennessee 38120
United StatesSite Not Available
Methodist University Hospital
Memphis 4641239, Tennessee 4662168 38120
United StatesSite Not Available
Valley Baptist Medical Center
Harlingen, Texas 78520
United StatesSite Not Available
Valley Baptist Medical Center
Harlingen 4696233, Texas 4736286 78520
United StatesSite Not Available
Harborview Medical Center
Seattle, Washington 98104
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Harborview Medical Center
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
Virginia Mason Medical Center
Seattle 5809844, Washington 5815135 98101
United StatesSite Not Available

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