Patient & Relative Information Sheet

In this hospital, patients with head injury are given the usual emergency treatment for head injury. They are also given, by a drip into the arm, a treatment as part of a study that is trying to find ways to improve recovery after head injury.
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The treatment in the drip is saline with either an active steroid (called methylprednisolone) or an inactive, dummy medicine included in it.  The choice of what to give was made randomly by a computer in Oxford.  The doctors looking after you do not know whether you got the active or the inactive medicine.  This information is kept on a confidential list at another hospital.
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All patients in the study, whether or not they got steroids, get the best care available.
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The steroid may help recovery by slightly reducing the brain swelling that can occur after head injury.  But steroids may make people slightly more prone to infection.  We hope to find that steroids do a little more good than harm, but we don't yet know this. The study is being carried out in hospitals in Britain as well as overseas, and will include many hundreds of patients with head injury.
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The study involves no extra tests, but we send brief details about how you have been in hospital to the trial centre in London, and about six months after your injury, we will contact you to ask how you are getting on.  This information would be used in strict confidence by the people working on the study and would not be released under any circumstances.
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If you have any questions about your care, please ask your doctor.
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