Minimally Invasive Surgery vs Medical Management Alone for Intracerebral Hemorrhage: The MIND Randomized Clinical Trial
Abstract
Importance: It remains uncertain whether surgical evacuation improves functional outcomes in patients with supratentorial intracerebral hemorrhage (ICH).
Objective: To compare the safety and efficacy of minimally invasive surgery with the Artemis Neuro Evacuation Device to guideline-based medical management alone for spontaneous supratentorial ICH.
Design, setting, and participants: The MIND open-label, multicenter randomized clinical trial randomized patients with spontaneous supratentorial ICH in a 2:1 ratio to either minimally invasive surgery or medical management alone. Participants were enrolled at 32 participating global sites between February 6, 2018, and August 28, 2023. This article reports on the primary trial outcome. Of 4066 eligible adult patients (aged 18-80 years) with moderate- to large-volume supratentorial ICH (20-80 mL), baseline National Institutes of Health Stroke Scale score of 6 or higher, and Glasgow Coma Scale score between 5 and 15, 154 were randomized to minimally invasive surgery and 82 to medical management. Data were analyzed from February to September 2024.
Intervention: Minimally invasive surgery (within 72 hours of symptom onset) plus medical management or medical management alone.
Main outcomes and measures: The primary efficacy outcome was 180-day combined death and disability via ordinal modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]). The primary safety outcome was 30-day mortality.
Results: Following an independent…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 4,066 participants or records.
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