In March 2011, investigators from Australia and several other countries published the results of the DECRA trial in the New England Journal of Medicine. This was a randomized trial comparing decompressive craniectomy to best medical therapy run between 2002 and 2010 to assess the optimal management of patients with medically refractory ICP following diffuse non-penetrating head injury. The study investigators found that decompressive craniectomy was associated with worse functional outcomes, as measured by a standard metric, than best medical care. There were no differences in deaths between groups. However, the results of the DECRA trial have been rejected or at least questioned by many practicing neurosurgeons, and a concurrently published editorial raises several study weaknesses.
First, the threshold for defining increased ICP, and the time allowed before declaring ICP medically refractory, are not what many practicing physicians would consider increased or refractory. Second, out of almost 3500 potentially eligible patients, only 155 patients were enrolled, showing that the study cannot be generalized to all patients with severe non-penetrating brain injury. Lastly, despite being randomized, more patients in the craniectomy arm had unreactive pupils (after randomization but before surgery) than patients in the medical therapy arm, a potential confounding factor.
The DECRA trial, an RCT that compared bifrontotemporoparietal DC 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.”