Clinical Trials

Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years
* Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method
* NIHSS ≥ 6 at presentation
* Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion
* Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (LAR) to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal of care (explicitly explained as <7 days following ictus)
* The treating physician anticipates that surgery can be initiated <120 min from randomization
* Randomization can occur ≤16 hours from LKW

Exclusion Criteria:

* Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct Infratentorial or thalamic hemorrhage
* Midbrain extension/involvement
* Coagulopathy defined as international normalized ratio (INR) > 1.4
* Elevated activated Partial Thromboplastin Time (aPTT) > 40 s
* Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset
* Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
* Platelet count <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed) GCS score <7 at presentation
* Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment
* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days
* Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles
* Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)
* Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule
* Current participation in another interventional (drug or device) trial
* Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status
* History of severe dementia

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/23/2026. Questions regarding updates should be directed to the study team contact.