About this trial
MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized \<8 hours from onset, and 2) those randomized 8-16 hours from onset. Randomization is targeted to occur within 120 min of arrival to the randomizing center's Emergency Department (ED), and initiation of surgery is targeted to occur within 120 min of randomization. Participants will be followed at 30, 90, 180, and 365 days to assess for adverse events (AEs) and utility-weighted modified Rankin Scale (UW-mRS).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Endoscopic ICH evacuation
- Standard Medical Treatment
Treatment groups
Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Medical University of South Carolina
Collaborator
NINDS Stroke Trials Network (StrokeNet)
Collaborator