CRASH is a large simple, placebo controlled trial of the effects of a 48-hour infusion of corticosteroids on death and on neurological disability, among adults with head injury and some impairment of consciousness.
Head injured patients with impaired consciousness who are judged to be 16 years or older are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use corticosteroids. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation involves calling a 24-hour freephone service. The call should last only a minute or two, and at the end of it the service will specify to the caller which numbered treatment pack to use. The drug or placebo in the pack is made up in saline and, following a one-hour loading dose, is infused over 48 hours (or as close to 48 hours as possible). No extra tests are required, but a short form is to be completed two weeks later (or after prior death or discharge). Long term recovery will be assessed at six months either by a simple questionnaire, sent directly to each trial participant from the CRASH Co-ordinating Centre, or by telephone interview. This does not involve any additional work for collaborating hospitals
Eligibility: Head injured patients (judged to be 16 years or older) within 8 hours of injury who are not fully conscious (any abnormality on the Glasgow Coma Scale), except those for whom corticosteroids are thought to be clearly indicated or contra-indicated.
Sponsors: This resource is supported by the London School of Hygiene & Tropical Medicine.
Keywords: Placebo, Drug, Corticosteroid, Death, Neurological, Disability, Adult, Head, Injury, Impairment, Consciousness, Test, Trial, Study,
Resource Type: Resource
Version: Latest Version
Additional Resource Types
topical portal, experimental protocol
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Created 4 years ago by Anonymous