Overview

The main purpose of this study is to compare patients with a deep bleed in the brain undergoing surgery to patients receiving routine medical care. The standard treatment involves admission to the Intensive Care Unit (ICU) with close monitoring and blood pressure control. It also includes other medical (non-surgical) treatments to prevent more bleeding or another stroke. Sometimes, doctors will recommend surgery to remove the blood if medical treatment alone is not successful.

There is evidence that doing minimally invasive surgery early-using a small opening in the skull to remove blood-may help some patients. Researchers aim to understand whether this surgery is better than current medical treatment, which may include surgeries to relieve pressure on the brain in some cases. This study, called REACH, is comparing usual medical care to early minimally invasive surgery so doctors can know which is better for patients.

Eligibility

Inclusion Criteria:

• 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

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 (less than 1 year) ICH, as diagnosed with radiographic 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 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
• 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)
• 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 than or 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 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 post-menopausal
• Known life expectancy of less than 6 months before ICH
• No reasonable expectation of recovery, do-not-resuscitate (DNR), or comfort measures only before randomization
• Participation in a concurrent interventional medical investigation or clinical trial. Patients in non-interventional/observational studies are eligible
• Inability or unwillingness of the subject or legal guardian/representative to give written informed consent
• Homelessness or inability to meet follow-up requirements