Limitations
death, VTE
This study has some limitations. First, outside of the audits, no data were available on whether patients received their intended treatment, and as-treated analyses could not be performed. However, the hospital audits conducted during the trial included both enrolled and nonenrolled patients and demonstrated high adherence rates. Second, some included patients may have received additional forms of anticoagulation (eg, DOACs, warfarin, or dual antiplatelet medications). Although the number of these patients could not be measured, it was assumed that they were balanced between groups (as they were for the primary study). Third, data on cause of death were not available. If available, this may have provided more specific information regarding the contribution of VTE prophylaxis to mortality. Fourth, despite the large sample size, due to the early cessation of the trial, the study was likely underpowered, given the between-group difference found and the results of the post hoc power calculation. Fifth, data on race and ethnicity were not collected for each group. However, the randomized study design would be expected to minimize unknown confounding.