Extrait

Background and study aims When someone has a stroke caused by bleeding into the brain (haemorrhagic stroke) permanent brain damage can occur and result in long-term disability. There is also a chance that the bleeding can increase, which may cause worse disability or be life threatening. This happens in approximately 20-30% of haemorrhagic stroke patients. At present there is no available treatment that is effective at reducing the bleeding in the brain and improving the recovery. In this trial, we want to test whether it is possible to give a drug (tranexamic acid) to people in the first few hours after a haemorrhagic stroke. We hope that we will be able to show that giving the drug may reduce the chances of dying and being left with disability after a haemorrhagic stroke. In this trial, the treatment we are testing is a drug, tranexamic acid, which encourages blood to clot to stop the bleeding. Continued or increased bleeding into the brain (haematoma expansion) is not uncommon in the first hours and days following a haemorrhagic stroke and increases the risk of the patient not recovering fully and being left with some disability. Stopping the bleeding in the first hours and days after stroke with medicine might help patients to recover better. Tranexamic acid is a tried and tested drug in other medical conditions that acts quickly to help the blood to clot and stop bleeding but is not given routinely after stroke. We aim to assess in this trial what effect tranexamic acid has on how people recover after a haemorrhagic stroke. Who can participate? Adults with an acute stroke caused by bleeding in the brain, within 8 hours of stroke onset. Participants will need to be able to complete all of the assessments, and will not have a diagnosis of another medical condition that is likely to interfere with the trial (e.g. terminal illness or pregnancy). Participants cannot be participating in other trials that are testing drugs. What does the study involve? Each participant’s involvement in the study will last for 90 days. We select which treatment you receive randomly (like tossing a coin). Half of the participants will receive an injection of the drug tranexamic acid and the other half will have an injection of salt water as a dummy (placebo) treatment. The treatment (either tranexamic acid or dummy) will be given as an injection as soon as possible once participants have decided they wish to take part in the study. The treatment will be given via a drip over about 8 hours. You will not know if you received the drug or the dummy. The treatment will be given once, and then the treatment will stop. During the next 7 days a nurse will check the participant’s condition, looking in particular for signs of side effects of the treatment. We will also repeat a brain scan the day after the treatment to assess the effects of the treatment. We will ask your permission to contact your GP or check with the NHS Information Centre to check on your condition 3 months after the stroke and to confirm contact details. You will then be contacted for a telephone consultation with a member of the research team. It will involve asking how you feel life has been affected by the stroke and some brief memory tests. What are the possible benefits and risks of participating? Because tranexamic acid is already routinely used in a number of bleeding conditions, we expect the potential benefit of the drug (stopping bleeding into the brain) to outweigh the low risk of serious side effects (such as blood clots). However, we do not know this for certain and will monitor all participants closely for side effects. Treatment with any drugs can result in possible side effects, but the side effects from tranexamic acid are generally mild. They can include diarrhoea, low blood pressure and dizziness. The drug can also sometimes affect colour vision but this is rare. However, because the treatment works by stopping bleeding there is a chance it can cause an increase in blood clot formation. This can occur in the legs (deep vein thrombosis, DVT) or the lungs (pulmonary embolism, PE) and is potentially very serious and maybe even life-threatening. In a very large study in 20,000 people with serious bleeding, tranexamic acid was safe and reduced the number of people dying from bleeding. There was no increase in serious side effects, such as blood clots, in the patients who were treated with tranexamic acid. Where is the study run from? The study is being run from the University of Nottingham but is a multi centre trial, with centres in the UK and Italy. When is the study starting and how long is it expected to run for? March 2013 to February 2017 Who is funding the study? The National Institute of Health Research (NIHR) (UK) Who is the main contact? Dr Nikola Sprigg [email protected]

Critère d'inclusion

• Stroke

Liens

• ictrp
• isrctn