Phase
Condition
Thrombosis
Brain Injury
Stroke
Treatment
Medical Management
Surgical management
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-70 years
Pre-randomization head CT demonstrating an acute, spontaneous, anterior basalganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia includethe caudate, putamen, and pallidum to the capsula externa and excludes the thalamus)
ICH volume between 20 - 80 mL as calculated by an approved and standardizedvolumetric measurement
Study intervention can reasonably be initiated within 24 hours after the onset ofstroke symptoms. If the onset is unclear, then the onset will be considered the timethat the subject was last known to be well.
Glasgow Coma Score (GCS) 5 - 14
Historical Modified Rankin Score 0 or 1
Exclusion
Exclusion Criteria:
Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoyadisease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of anischemic infarct, recurrence of a recent (less than 1 year) ICH, as diagnosed withradiographic imaging
NIH Stroke Scale (NIHSS) less than or equal to 5
Bilateral fixed dilated pupils
Extensor motor posturing
Intraventricular extension of the hemorrhage is visually estimated to involvegreater than 50% of either of the lateral ventricles
Primary thalamic ICH or basal ganglia hemorrhage with involvement > 25% of thalamus
Infratentorial intraparenchymal hemorrhage including midbrain, pontine, orcerebellar
Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met ifinvestigators are confident that clinically significant coagulopathy is not presentafter targeted correction)
Evidence of active bleeding involving a retroperitoneal, gastrointestinal,genitourinary, or respiratory tract site
Uncorrected coagulopathy or known clotting disorder
Known platelet count less than 75,000 or known international normalized ratio (INR)greater than 1.4 after correction
Patients requiring long-term anti-coagulation that needs to be initiated less thanor equal to 5 days from initial 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 siteinvestigator, would interfere with adherence to study requirements
Positive urine or serum pregnancy test in female subjects without documented historyof surgical sterilization or post-menopausal
Known life expectancy of less than 6 months before ICH
No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measuresonly before randomization
Participation in a concurrent interventional medical investigation or clinicaltrial. Patients in non-interventional/observational studies are eligible
Inability or unwillingness of the subject or legal guardian/representative to givewritten informed consent
Homelessness or inability to meet follow-up requirements
Study Design
Study Description
Connect with a study center
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
Stanford University Medical Center
Palo Alto, California 94304
United StatesSite Not Available
Baptist Health Jacksonville FL
Jacksonville, Florida 32207
United StatesActive - Recruiting
Baptist Health South Florida
Kendall, Florida 33176
United StatesSite Not Available
Jackson Memorial Hospital (JMH)
Miami, Florida 33125
United StatesSite Not Available
Baptist Health Jacksonville FL
Jacksonville 4160021, Florida 4155751 32207
United StatesSite Not Available
Emory Hospital Midtown
Atlanta, Georgia 30308
United StatesActive - Recruiting
Emory University Hospital (EUH)
Atlanta, Georgia 30322
United StatesActive - Recruiting
Grady Memorial Hospital
Atlanta, Georgia 30303
United StatesActive - Recruiting
Emory Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
United StatesActive - Recruiting
Emory University Hospital (EUH)
Atlanta 4180439, Georgia 4197000 30322
United StatesActive - Recruiting
Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30303
United StatesSite Not Available
Rush University
Chicago, Illinois 60612
United StatesSite Not Available
Endeavor Health, Northshore
Evanston, Illinois 60201
United StatesActive - Recruiting
Rush University
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Endeavor Health, Northshore
Evanston 4891382, Illinois 4896861 60201
United StatesSite Not Available
Goodman Campbell Brain and Spine
Carmel, Indiana 46032
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Johns Hopkins School of Medicine
Baltimore, Maryland 21287
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65212
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesActive - Recruiting
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesActive - Recruiting
Montefiore Medical Center/Albert Einstein School of Medicine
The Bronx, New York 10467
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
ProMedica Toledo Hospital
Toledo, Ohio 43606
United StatesActive - Recruiting
Rhode Island Hospital/Brown University Health
Providence, Rhode Island 02912
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available

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