Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months.
Level 2 - randomized trial
Large randomized placebo-controlled multicenter trial
PubMed 15936423 · doi:10.1016/S0140-6736(05)66552-X
What was done
In the multicenter MRC CRASH trial, 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less presenting within 8 hours of injury were randomized to receive a 48-hour intravenous infusion of corticosteroid (methylprednisolone) or placebo. Outcomes at 6 months were obtained for 9,673 (96.7%) participants.
What was found
At 6 months, the risk of death was significantly higher in the corticosteroid group than in the placebo group (1,248 [25.7%] vs 1,075 [22.3%]; relative risk 1.15, 95% CI 1.07-1.24; p=0.0001). The combined risk of death or severe disability was 1,828 (38.1%) with corticosteroids versus 1,728 (36.3%) with placebo (relative risk 1.05, 95% CI 0.99-1.10; p=0.079). The effect did not differ by baseline injury severity or time from injury to treatment.
Why it matters
This trial conclusively demonstrated that routine corticosteroid administration increases mortality in acute traumatic brain injury, refuting earlier clinical practice.
Limits
Follow-up at 6 months was incomplete for 335 (3.3%) patients. The abstract does not provide data on specific causes of death, adverse events, or functional outcomes beyond 6 months.
Cited by
- supports The CRASH trial evaluating corticosteroid anti-inflammatories for head injury found an absolute increase in death rate of 3.8% compared to placebo.