Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.

摘要: Background Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk death by 1-2%. The CRASH trial--a multicentre international collaboration--aimed confirm or refute such an effect recruiting 20000 patients. May, 2004, the data monitoring committee disclosed unmasked results steering committee, which stopped recruitment. Methods 10008 adults with injury and Glasgow coma score (GCS) 14 less within 8 h were randomly allocated 48 infusion corticosteroids (methylprednisolone) placebo. Primary outcomes 2 weeks disability at 6 months. Prespecified subgroup analyses based on severity randomisation time from randomisation. Analysis was intention treat. Effects are presented in this report. This study is registered as International Standard Randomised Controlled Trial, number ISRCTN74459797. Findings Compared placebo, all causes higher group (1052 [21.1%] vs 893 [17.9%] deaths; relative 1.18 [95% CI 1.09-1.27]; p=0.0001). increase deaths due did not differ (p=0.22) since (p=0.05). Interpretation Our show there no reduction mortality methylprednisolone after injury. cause rise unclear.