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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
ISRCTN ISRCTN74459797
DOI 10.1186/ISRCTN74459797
ClinicalTrials.gov identifier
EudraCT number
Public title A large simple placebo controlled trial, among adults with head injury and impaired consciousness, of the effects of corticosteroids on death and disability
Scientific title
Acronym CRASH
Serial number at source G9722166
Study hypothesis 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

Protocol can be found at: http://www.crash.lshtm.ac.uk/Trial_Protocol_English.html
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Neuroscience, psychiatry
Participants - inclusion criteria 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. 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.
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/04/1999
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material Patient information can be found at: http://www.crash.lshtm.ac.uk/TP_English_PatRelSheet.htm
Target number of participants 10000
Interventions 1. Intervention: 48 hour infusion of methylprednisolone (MP) (0.4 g/h for 48 hours)
2. Control: placebo infusion
Primary outcome measure(s) 1. Death from any cause within two weeks of injury
2. Death or dependence at six months
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Medical Research Council (MRC) (UK)
Trial website http://www.crash.lshtm.ac.uk/
Publications 2001 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/11439175
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15474134
2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/15936423
Contact name Dr  Ian  Roberts
  Address CRASH Co-ordinating Centre
Institute of Child Health
30 Guilford Street
  City/town London
  Zip/Postcode WC1N 1EH
  Country United Kingdom
  Email
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7636 8636
  Fax +44 (0)20 7436 5389
  Email
  Sponsor website: http://www.lshtm.ac.uk
Date applied 23/10/2000
Last edited 11/07/2014
Date ISRCTN assigned 23/10/2000
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