Abstract
BACKGROUND: Enoxaparin was shown to have a neuroprotective effect in animal models as well as a human study following traumatic brain injury. This study was conducted to assess the effect of enoxaparin on the clinical outcome of severe traumatic brain injury (TBI) and its safety. METHODS: This study is a randomized double-blinded placebo-controlled trial. The inclusion criteria were age 16-70, a closed head injury, a postresuscitation Glasgow Coma Scale (GCS) between 5 and 8, and a latency time between the injury and entering the study of less than 5 h. The patients were randomized into enoxaparin and placebo groups. In the enoxaparin group, 0.5 mg/kg enoxaparin was injected subcutaneously every 6 h in six total doses. The two groups were compared for the occurrence of intracranial hematoma (ICH) and for clinical neurological outcome, assessed by the Glasgow Outcome Scale. RESULTS: Twenty-seven patients were assigned to the placebo group and 26 to the enoxaparin group. The two groups were similar regarding baseline characteristics, including age, sex, postresuscitation GCS, and best motor response. The occurrence of new ICH or an ICH size increase was insignificantly more frequent in the enoxaparin group than the placebo group (26.9% vs. 7.4%, P = 0.076). The favorable outcome rate in the enoxaparin group was significantly higher than in the placebo group (57.7% vs. 25.9%, P = 0.019). CONCLUSIONS: This study showed that the early administration of enoxaparin could lead to favorable outcomes in severe TBI patients without significantly increasing cerebral hemorrhagic complications.