Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
11/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.crash.lshtm.ac.uk/

Contact information

Type

Scientific

Primary contact

Dr Ian Roberts

ORCID ID

Contact details

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

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 measures

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

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

http://www.lshtm.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. Protocol

    , , The CRASH trial protocol (Corticosteroid randomisation after significant head injury) [ISRCTN74459797]., BMC Emerg Med, 2001, 1, 1, 1.

  2. 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.

  3. 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.

Additional files

Editorial Notes