Effect of intravenous corticosteroids on death within 14 days in 10 008 adults with clinically significant head injury: randomised placebo-controlled trial

Roberts et al for the CRASH trial collaborators. Lancet 2004; 364:1321-28. doi:10.1016/S0140-6736(04)17188-2

Clinical Question

• In adults with a head injury, do early corticosteroids compared to placebo reduce death and disability?
  N = 10 008, 239 hospitals in 49 countries

Outcome

• Primary outcome: unmasking of randomisation took place after 10,008 patients due to a clear difference favouring placebo for mortality at 2-weeks
  • Corticosteroid group 21% mortality vs placebo group 18% mortality
  • Relative risk 1.18 (95% CI 1.09–1.27; p=0.0001)
  • Absolute risk increase 3.15% (95% CI 1.60%–4.70%; NNH 32)
• Secondary outcome: 6-month follow-up favoured placebo for mortality and severe disability

Authors’ Conclusions

Corticosteroids should not be used routinely to treat head injury, whatever the severity.

The Bottom Line

Corticosteroids should not be given to patients with head injuries, unless other specific indications exist that outweigh the increased risk of death demonstrated by this trial