The DECRA trial, an RCT that compared bifrontotemporoparietal decompressive craniectomy to initial medical management for refractory raised ICP, recruited patients in 15 tertiary care hospitals in Australia, New Zealand, and Saudi Arabia between December 2002 and April 2010.
This study found poorer GOS-E scores for patients in the DC group than those in standard care at 6 months post- injury, and lower ICP and fewer ICU days for patients in the DC group. Despite randomization, the proportion of patients in the DC group with reactivity in neither pupil on admission was higher (27% vs. 12%, p=0.04) than in controls. Planned baseline covariate adjustment did not change the results, but post hoc adjustment for this difference in pupil reactivity at admission resulted in outcome differences that were no longer significant. Based on this, the authors reported that “…the overall effect size did not change, although the harmful effect of craniectomy was no longer significant. A beneficial effect of craniectomy was excluded.” 1).