Phase
Condition
Hemorrhage
Stroke
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-related masseffect or shift due to trapped ventricle (EVD for ICP management is allowed)
- 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 factor deficiency
- 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 comply withprotocol 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 epidemiological studiesnot involving intervention are eligible.
Study Design
Connect with a study center
Uniklinikum Salzburg
Salzburg,
AustriaSite Not Available
University of Alberta
Edmonton, Alberta
CanadaSite Not Available
Universitätsklinikum Augsburg
Augsburg,
GermanySite Not Available
Charité - Universitätsmedizin Berlin
Berlin,
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg im Breisgau,
GermanySite Not Available
München Klinik Bogenhausen
München,
GermanySite Not Available
Abrazo Central
Phoenix, Arizona 85015
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
Mission Hospital
Mission Viejo, California 92691
United StatesSite Not Available
Swedish - HCA
Englewood, Colorado 80113
United StatesSite Not Available
Yale University
New Haven, Connecticut 06510
United StatesSite Not Available
Christiana Health
Newark, Delaware 19718
United StatesSite Not Available
George Washington
Washington, District of Columbia 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
University of Kentucky
Lexington, Kentucky 40506
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40292
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
University of Mississippi
Jackson, Mississippi 39216
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65211
United StatesSite Not Available
Atlantic Neuroscience Institute
Summit, New Jersey 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
Novant Health
Charlotte, North Carolina 28277
United StatesSite Not Available
University Hospital Cleveland
Cleveland, Ohio 44106
United StatesSite Not Available
OUHSC
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
MUSC
Charleston, South Carolina 29425
United StatesSite Not Available
Methodist University Hospital
Memphis, Tennessee 38120
United StatesSite Not Available
Valley Baptist Medical Center
Harlingen, Texas 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
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