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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74459797
Enrollment
10000
Registered
2000-10-23
Start date
1999-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroscience, psychiatry Injury, Occupational Diseases, Poisoning Head injury

Interventions

1. Intervention: 48 hour infusion of methylprednisolone (MP) (0.4 g/h for 48 hours) 2. Control: placebo infusion

Sponsors

London School of Hygiene and Tropical Medicine (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. Death from any cause within two weeks of injury 2. Death or dependence at six months

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 14, 2026