[HTML][HTML] Corticosteroids increased short and long-term mortality in adults with traumatic head injury

MS Czekajlo, EB Milbrandt - 2005 - Springer
MS Czekajlo, EB Milbrandt
2005Springer
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 of death by 1–
2%. The CRASH trial–a multicentre international collaboration–aimed to confirm or refute
such an effect by recruiting 20,000 patients. In May 2004, the data monitoring committee
disclosed the unmasked results to the steering committee, which stopped recruitment.
Methods 10,008 adults with head injury and a Glasgow coma score (GCS) of 14 or less …
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 of death by 1–2%. The CRASH trial–a multicentre international collaboration–aimed to confirm or refute such an effect by recruiting 20,000 patients. In May 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment.
Methods
10,008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 hours of injury were randomly allocated 48 hour infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2-weeks of injury and death or disability at 6-months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation were presented in this report.
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