1144 180-day MIND Study Results ─ A Prospective, Randomized, Multicenter Study Of 236 ICH Patients

INTRODUCTION: Until recently, multiple randomized controlled trials of conventional surgical evacuation and medical management have not shown statistically significant improvement in clinical outcomes in patients with supratentorial intracerebral hemorrhage (ICH). First positive results favoring minimally invasive surgery (MIS) for hematoma evacuation over medical management are just emerging, leaving many unanswered questions regarding optimal ICH treatment options. METHODS: MIND is a prospective, multicenter, two-arm, open-label treatment assignment study of adult patients with moderate-large volume supratentorial ICH (20-80 cc), presenting within 24 hours of symptom onset, randomized (2:1) based upon presenting condition (Hemphill Score 0-2 vs 3-4) and ICH location (lobar vs deep) into MIS or MM groups. Primary efficacy endpoint is 180-day global disability assessed via the ordinal modified Rankin score (mRS). Primary safety endpoint is 30-day mortality. Patients are followed through 365 days. RESULTS: At the N=200 interim analysis, the DSMB recommended to continue the trial amid no safety concerns. In the wake of the positive ENRICH trial results, randomization in the primary lobar arm was stopped. An independent feasibility analysis at N=236 resulted in stopping the enrollment altogether. Collection of the follow-up data continues. The data are unavailable at the abstract submission deadline and will be released at the conference. We plan to report baseline demographics, 180-day primary efficacy, 30-day mortality and safety events of interest, and ICU/hospital length of stay. We also plan to present outcome data on patients with deep ICH, i.e., a cohort comprising the majority of MIND cases while underrepresented in published literature.