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 |
| Secondary identifying numbers | G9722166 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 11/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Roberts
Scientific
Scientific
CRASH Co-ordinating Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
Study information
| Study design | Placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Patient information can be found at: http://www.crash.lshtm.ac.uk/TP_English_PatRelSheet.htm |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/1999 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CRASH Co-ordinating Centre
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
London School of Hygiene and Tropical Medicine (UK)
University/education
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7636 8636 |
|---|---|
| Website | http://www.lshtm.ac.uk |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/06/2001 | Yes | No | |
| Results article | results | 01/10/2004 | Yes | No | |
| Results article | results | 01/06/2005 | Yes | No |
