Condition: Basal Ganglia Intracerebral Hemorrhage · Sponsor: Icahn School of Medicine at Mount Sinai
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).
This description comes directly from the study's public registry record.
Ally Qi, MPH · 2093303024 · ally.qi@mountsinai.org
Sukaina Davdani · sukaina.davdani@mountsinai.org
Always discuss trial participation with your own doctor first.
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey, United States | Recruiting |
| Mount Sinai Health System | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07260916