Decompressive Craniectomy in Diffuse Traumatic Brain Injury [DECRA Trial]
- Study aims at assessing whether decompressive craniectomy can improve functional outcomes in patients with severe traumatic brain injury (TBI) and refractory elevation of intracranial pressure (ICP).
- Multi-center, randomized, controlled trial.
- Patients with severe TBI not responding to first-tier therapy were randomly assigned within 72 hours to Craniectomy group plus standard care, or Standard-Care only group.
- 155 patients were randomized.
- Elevated ICP defined as >20 mmHg for >15 mins within a 1-hour period
- Craniectomy group (n=73) underwent bifrontotemporoparietal craniectomy, with bilateral dural opening. The sagittal sinus and falx cerebri were not divided.
- Standard-care only group (n=82) followed clinical practice guidelines recommended by the Brain Trauma Foundation. After 72 hours, the trial allowed providing lifesaving decompressive craniectomy (n=4).
- Original primary outcome was an unfavorable outcome (death, vegetative state, or severe disability) using the Extended Glasgow Outcome Scale at 6 months. The final primary outcome was the score on the Scale at 6 months.
- Craniectomy group, compared to Standard-Care only group, had less time with elevated ICP above the pre-defined treatment threshold, fewer interventions for elevated ICP, and fewer length of stay in the ICU. However, craniectomy group also had worse scores on Extended Glasgow Outcome Scale, and greater risk of unfavorable outcome. All these findings were statistically significant.
- Rates of death at 6 months were similar: Craniectomy group (19%), Standard-Care only group (18%).
- Limitations: Medical and surgical treating teams could not be blinded to study group assignments. One center recruited more than third of patients.
- Conclusion: In patients with severe TBI and refractory ICP elevation, bifrontotemporoparietal craniectomy compared to standard care alone decreased mean ICP, duration of ICU stay and duration of ventilatory support, but was associated with more unfavorable outcome at 6 months (as measured by the score on the Extended Glasgow Outcome Scale).