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ISRCTN
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ISRCTN74459797
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DOI
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10.1186/ISRCTN74459797
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A large simple placebo controlled trial, among adults with head injury and impaired consciousness, of the effects of corticosteroids on death and disability
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Scientific title
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Acronym
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CRASH
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Serial number at source
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G9722166
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Study hypothesis
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The aim of the pilot phase was to determine whether a large-scale trial is feasible in the emergency setting, and to test and refine the study procedures for the main phase of the CRASH trial. The pilot phase was to be conducted over a one-year period.
The CRASH trial aims to determine reliably:
1. The effects of high dose corticosteroid infusion on death and on disability following significant head injury
2. The effects of such infusion on the risk of infection and of gastro-intestinal bleeding in this setting
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Placebo controlled trial
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Countries of recruitment
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United Kingdom, International
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Disease/condition/study domain
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Neuroscience, psychiatry
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Participants - inclusion criteria
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Head injured patients (judged to be 16 years or older) within eight 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. There are no other pre-specified exclusion criteria, as the fundamental eligibility criterion is the responsible doctor's uncertainty whether or not to use corticosteroids in a particular adult with head injury.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/04/1999
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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10000
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Interventions
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1. Intervention: 48 hour infusion of methylprednisolone (MP) (0.4 g/h for 48 hours)
2. Control: placebo infusion
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Primary outcome measure(s)
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1. Death from any cause within two weeks of injury
2. Death or dependence at six months
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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http://www.crash.lshtm.ac.uk/
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Publications
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1. Protocol on http://www.ncbi.nlm.nih.gov/pubmed/11439175
2. Results on http://www.ncbi.nlm.nih.gov/pubmed/15474134
3. Final results on http://www.ncbi.nlm.nih.gov/pubmed/15936423
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Contact name
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Dr
Ian
Roberts
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Address
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CRASH Co-ordinating Centre
Institute of Child Health
30 Guilford Street
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City/town
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London
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Zip/Postcode
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WC1N 1EH
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Country
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United Kingdom
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Email
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Sponsor
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London School of Hygiene and Tropical Medicine (UK)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 8636
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Fax
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+44 (0)20 7436 5389
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Email
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Sponsor website:
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http://www.lshtm.ac.uk
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Date applied
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23/10/2000
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Last edited
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14/08/2008
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Date ISRCTN assigned
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23/10/2000
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