Rapid removal of deep brain clots with minimally invasive surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Baptist Health Jacksonville FL
  Jacksonville, Florida, United States Recruiting
• Baptist Health South Florida
  Kendall, Florida, United States Recruiting
• University of Miami Health System, Jackson Memorial Hospital
  Miami, Florida, United States Recruiting
• Grady Memorial Hospital
  Atlanta, Georgia, United States Recruiting
• Emory Hospital Midtown
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Alex Hall, DHSc — Emory University
• Study coordinator: Alex Hall, DHSc
• Email: alex.hall@emory.edu
• Phone: 404-778-1585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.