Rapid Evacuation and Access of Cerebral Hemorrhage Trial

Korábbi kezelés

• Known life expectancy of less than 6 months before ICH
• Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible

Más betegség

• 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 (less than 1 year) ICH, as diagnosed with radiographic imaging
• NIH Stroke Scale (NIHSS) less than or equal to 5
• Intraventricular extension of the hemorrhage is visually estimated to involve greater 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, or cerebellar
• Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
• Uncorrected coagulopathy or known clotting disorder
• 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

Laborértékek

• Known platelet count less than 75,000 or known international normalized ratio (INR) greater than 1.4 after correction
• Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or post-menopausal

Egyéb

• Bilateral fixed dilated pupils
• Extensor motor posturing
• Use of anticoagulants that cannot be rapidly reversed (i.e., criteria is met if investigators are confident that clinically significant coagulopathy is not present after targeted correction)
• Patients requiring long-term anti-coagulation that needs to be initiated less than or equal to 5 days from initial ICH
• No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
• Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
• Homelessness or inability to meet follow-up requirements

• Age 18-70 years
• Pre-randomization head CT demonstrating an acute, spontaneous, anterior basal ganglia primary intracerebral hemorrhage (ICH) (the anterior basal ganglia include the caudate, putamen, and pallidum to the capsula externa and excludes the thalamus)
• ICH volume between 20 - 80 mL as calculated by an approved and standardized volumetric measurement
• Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the 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