Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9722166
Study information
Scientific title
Acronym
CRASH
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
Ethics approval
Not provided at time of registration
Study design
Placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Patient information can be found at: http://www.crash.lshtm.ac.uk/TP_English_PatRelSheet.htm
Condition
Neuroscience, psychiatry
Intervention
1. Intervention: 48 hour infusion of methylprednisolone (MP) (0.4 g/h for 48 hours)
2. Control: placebo infusion
Intervention type
Drug
Phase
Not Specified
Drug names
Methylprednisolone
Primary outcome measure
1. Death from any cause within two weeks of injury
2. Death or dependence at six months
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1999
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
10000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1999
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
CRASH Co-ordinating Centre
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
London School of Hygiene and Tropical Medicine (UK)
Sponsor details
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7636 8636
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Protocol
, , The CRASH trial protocol (Corticosteroid randomisation after significant head injury) [ISRCTN74459797]., BMC Emerg Med, 2001, 1, 1, 1.
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Results
Roberts I, Yates D, Sandercock P, Farrell B, Wasserberg J, Lomas G, Cottingham R, Svoboda P, Brayley N, Mazairac G, Laloë V, Muñoz-Sánchez A, Arango M, Hartzenberg B, Khamis H, Yutthakasemsunt S, Komolafe E, Olldashi F, Yadav Y, Murillo-Cabezas F, Shakur H, Edwards P, , Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial., Lancet, 364, 9442, 1321-1328, doi: 10.1016/S0140-6736(04)17188-2.
-
Results
Edwards P, Arango M, Balica L, Cottingham R, El-Sayed H, Farrell B, Fernandes J, Gogichaisvili T, Golden N, Hartzenberg B, Husain M, Ulloa MI, Jerbi Z, Khamis H, Komolafe E, Laloë V, Lomas G, Ludwig S, Mazairac G, Muñoz Sanchéz Mde L, Nasi L, Olldashi F, Plunkett P, Roberts I, Sandercock P, Shakur H, Soler C, Stocker R, Svoboda P, Trenkler S, Venkataramana NK, Wasserberg J, Yates D, Yutthakasemsunt S, , Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months., Lancet, 365, 9475, 1957-1959, doi: 10.1016/S0140-6736(05)66552-X.