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	https://doi.org/10.1186/ISRCTN74459797
Protocol serial number	G9722166
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ian Roberts
Scientific

CRASH Co-ordinating Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Primary study design	Interventional
Study design	Placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	CRASH
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methylprednisolone
Primary outcome measure(s)	1. Death from any cause within two weeks of injury 2. Death or dependence at six months
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	10000
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1999
Date of final enrolment	31/12/2005

CRASH Co-ordinating Centre

London
WC1N 1EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2004		Yes	No
Results article	results	01/06/2005		Yes	No
Protocol article	protocol	11/06/2001		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes