Loading...
This multicenter, multinational, randomized, controlled trial was conducted to better determine whether hypothermia is beneficial for children with severe traumatic brain injury. Patients in the hypothermia group were cooled to 32° C to 33° C and maintained there for 48 to 72 hours before being slowly rewarmed.
The study was stopped early for futility. At the time of the interim analysis, 39 patients had been randomized to hypothermia and 38 to normothermia. The primary outcome measure, all-cause mortality within 3 months after injury, had occurred in 6 of 39 (15%) in the hypothermia group, and 2 of 38 (5%) in the normothermia group, a nonsignificant difference. Outcomes were also similar between groups on secondary measures of global functi…