Rapid removal of deep brain clots with minimally invasive surgery
Rapid Evacuation and Access of Cerebral Hemorrhage Trial
This trial will test whether early minimally invasive surgery to remove deep brain clots helps adults (18–70) with spontaneous basal ganglia hemorrhage compared with usual medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 21 sites (Little Rock, Arkansas and 20 other locations) |
| Trial ID | NCT06870812 on ClinicalTrials.gov |
What this trial studies
Adults with an acute spontaneous intracerebral hemorrhage located in the anterior basal ganglia and a clot volume of 20–80 mL are enrolled and randomly assigned to either early minimally invasive surgical clot removal or standard medical management. The surgical approach uses a small opening to evacuate the hematoma and aims to start intervention within 24 hours of symptom onset. Clinical outcomes such as functional recovery and survival are followed to determine whether the surgical approach leads to better results than current ICU-based medical care. Sites include academic medical centers and the study is led by Emory University with participation from several regional hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults 18–70 years old with a spontaneous anterior basal ganglia intracerebral hemorrhage measuring 20–80 mL on CT, able to start the assigned intervention within 24 hours, with pre-stroke function of mRS 0–1 and a GCS of 5–14.
Not a fit: Patients with other vascular lesions (aneurysm, AVM, Moyamoya), thalamic or hemorrhagic conversion of infarct, very small or very large bleeds, or who present outside the 24-hour window are unlikely to benefit from this study intervention.
Why it matters
Potential benefit: If successful, this approach could improve recovery and reduce death or long-term disability for patients with deep intracerebral hemorrhage.
How similar studies have performed: Previous trials have shown benefit from minimally invasive clot removal for more superficial lobar hemorrhages, but its effectiveness in deeper basal ganglia hemorrhages is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Little Rock, Arkansas and 20 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Not_yet_recruiting)
- Stanford University Medical Center — Palo Alto, California, United States (Not_yet_recruiting)
- Baptist Health Jacksonville FL — Jacksonville, Florida, United States (Recruiting)
- Baptist Health South Florida — Kendall, Florida, United States (Not_yet_recruiting)
- Jackson Memorial Hospital (JMH) — Miami, Florida, United States (Not_yet_recruiting)
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
- Emory Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital (EUH) — Atlanta, Georgia, United States (Recruiting)
- Rush University — Chicago, Illinois, United States (Not_yet_recruiting)
- Endeavor Health, Northshore — Evanston, Illinois, United States (Recruiting)
- Goodman Campbell Brain and Spine — Carmel, Indiana, United States (Not_yet_recruiting)
- University of Kentucky — Lexington, Kentucky, United States (Not_yet_recruiting)
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of Missouri — Columbia, Missouri, United States (Not_yet_recruiting)
- Albany Medical Center — Albany, New York, United States (Recruiting)
- SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
- Montefiore Medical Center/Albert Einstein School of Medicine — The Bronx, New York, United States (Not_yet_recruiting)
- The Ohio State University — Columbus, Ohio, United States (Not_yet_recruiting)
- ProMedica Toledo Hospital — Toledo, Ohio, United States (Recruiting)
- Rhode Island Hospital/Brown University Health — Providence, Rhode Island, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Alex Hall, DHSc — Emory University
- Study coordinator: Alex Hall, DHSc
- Email: alex.hall@emory.edu
- Phone: 404-778-1585
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.