Extrait

Background and study aims Following injury to the head, the brain, just like any other part of the body, becomes bruised and swollen. This swelling occurs in the confines of the rigid skull and results in an increase in pressure and reduction in blood and oxygen supply to the brain. Treatment in the intensive care unit is directed at controlling swelling and pressure and maintaining a good blood and oxygen supply to the brain. There are a number of conventional treatments that are used to achieve this, including the ventilator to support breathing and various drugs to support blood pressure and reduce swelling directly. Whilst these treatments are effective in some patients, others with more severe swelling are at an increased risk. Currently there are two advanced methods to control brain swelling. The first is the use of an operation called a decompressive craniectomy. In this operation a part of the skull bone is removed (front or side) leaving the brain protected by the membranes and scalp. This creates an opening for the brain, helping to control swelling and high pressure. The opening is later repaired using the original bone or a synthetic plate. The second available method is to use strong drugs to control the activity in the brain. The benefit of each of these treatments, and which method is more effective for a particular type of patient, are currently unclear. This study is being conducted to try to find out which is the best method of treatment. We to enrol approximately 400 participants around the world (200 in the group receiving the operation to control the swelling and 200 in the group receiving medical treatment with stronger drugs). Who can participate? Participants must have sustained a head injury, be between the ages of 10 and 65 years, with an abnormal CT scan requiring intra-cranial pressure (ICP) monitoring and raised ICP that has not been successfully managed by the initial medical treatment. What does the study involve? If the patient requires these more advanced measures to control pressure and swelling, they will be randomly allocated to one of two groups: either the operation to control the swelling or advanced medical treatment. If either treatment is not effective, then the alternative treatment can be provided. A computerised tomography (CT) scan, which uses x-rays and a computer to create detailed images of the inside of your body, will be taken on admission to hospital and before random allocation to one of the two groups (randomisation). These scans are considered routine for this type of injury and pose no additional risk. At 6, 12 and 24 months following the head injury, you will be contacted in order to complete a questionnaire to assess your recovery. This will be done either by post, a telephone call or in the out patient clinic. The questionnaire takes approximately 30 minutes to complete. What are the possible benefits and risks of participating? If you chose to participate in the study, or allow your relative to, there may or may not be any direct benefit. Both treatments are considered to be standard treatments for this condition and are used routinely. It is hoped that the information gained from this study can be used in the future to benefit other people with similar conditions. Where is the study run from? Cambridge University and Cambridge University Hospitals Foundation Trust, UK. See participating centres on the study website http://www.rescueicp.com/frameset4.html When is the study starting and how long is it expected to run for? The study recruited its first patient in January 2004 and has a projected completion date of December 2014. Who is funding the study? National Institute of Health Research (NIHR) and the Medical Research Council (MRC), UK. Who is the main contact? Mr Peter Hutchinson [email protected]

Critère d'inclusion

• Severe traumatic brain injury

Liens

• ictrp
• isrctn