Very early administration of @entity1420 for acute XXXX .

@entity1 @entity131 @entity64 @entity1420 @entity16 @entity2 @entity2268 @entity3527 @entity204
BACKGROUND: @entity131 ( @entity131 ) is a major cause of @entity204 and disability worldwide. @entity1420 has been shown to improve neurologic outcome in multiple experimental models and two early-phase trials involving @entity1 with @entity131 . METHODS: We conducted a double-blind, multicenter clinical trial in which @entity1 with severe, moderate-to-severe, or moderate acute @entity131 (Glasgow Coma Scale score of 4 to 12, on a scale from 3 to 15, with lower scores indicating a lower level of consciousness) were randomly assigned to intravenous @entity1420 or placebo, with the study treatment initiated within 4 hours after injury and administered for a total of 96 hours. Efficacy was defined as an increase of 10 percentage points in the proportion of @entity1 with a favorable outcome, as determined with the use of the stratified dichotomy of the Extended Glasgow Outcome Scale score at 6 months after injury. Secondary outcomes included mortality and the Disability Rating Scale score. RESULTS: A total of 882 of the planned sample of 1140 @entity1 underwent randomization before the trial was stopped for futility with respect to the primary outcome. The study groups were similar with regard to baseline characteristics; the median age of the @entity1 was 35 years, 73.7% were @entity1 , 15.2% were black, and the mean Injury Severity Score was 24.4 (on a scale from 0 to 75, with higher scores indicating greater severity). The most frequent mechanism of injury was a motor vehicle accident. There was no significant difference between the @entity1420 group and the placebo group in the proportion of @entity1 with a favorable outcome (relative benefit of @entity1420 , 0.95; 95% confidence interval [CI], 0.85 to 1.06; P=0.35). @entity3527 or @entity2268 was more frequent in the @entity1420 group than in the placebo group (relative risk, 3.03; CI, 1.96 to 4.66). There were no significant differences in the other prespecified safety outcomes. CONCLUSIONS: This clinical trial did not show a benefit of @entity1420 over placebo in the improvement of outcomes in @entity1 with acute @entity131 . (Funded by the National Institute of @entity16 and @entity64 and others; @entity2 .gov number, NCT00822900.).
