• H E Hinson, Elizabeth Sun, Bradley J Molyneaux, Rüdiger von Kummer, Andrew Demchuk, Javier Romero, Taylor KimberlyWWDepartment of Neurology, Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: WTKIMBERLY@mgh.harvard.edu., and Kevin N Sheth.
• Departments of Neurology and Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, CR-127, Portland, OR 97239, USA. Electronic address: hinson@ohsu.edu.
• J Stroke Cerebrovasc Dis. 2020 Jul 1; 29 (7): 104916.

Background/ObjectiveMalignant edema can be a life-threatening complication of large hemispheric infarction (LHI), and is often treated with osmotherapy. In this exploratory analysis of data from the GAMES-RP study, we hypothesized that patients receiving osmotherapy had symptomatic cerebral edema, and that treatment with intravenous (IV) glibenclamide would modify osmotherapy use as compared with placebo.MethodsGAMES-RP was a phase 2 multi-center prospective, double blind, randomized, placebo-controlled study in LHI. Patients were randomized to IV glibenclamide (e.g. IV glyburide) or placebo. Cerebral edema therapies included osmotherapy and/or decompressive craniectomy at the discretion of the treating team. Total bolus osmotherapy dosing was quantified by "osmolar load". Radiographic edema was defined by dichotomizing midline shift at 24 h. Clinical changes were defined as any increase in NIHSS1a.ResultsOsmotherapy was administered to 40 of the 77 patients at a median of 39 [27-55] h after stroke onset. The median baseline DWI lesion volume was significantly larger in the osmotherapy treated group (167 [146-211] mL v. 139 [112-170] mL; P=0.046). Adjudicated malignant edema (75% v. 16%; P<0.001) was more common in the osmotherapy treated group. There were no differences in the proportion of patients receiving osmotherapy or the median total osmolar load between treatment arms. Most patients (76%) had a decrease in consciousness (NIHSS item 1A ≥1) on the day they began receiving osmotherapy.ConclusionsIn the GAMES-RP trial, osmolar therapies were most often administered in response to clinical symptoms of decreased consciousness. However, the optimal timing of administration and impact on outcome after LHI have yet to be defined.Published by Elsevier Inc.

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