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Nederland - Patient informatiebrief
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International - Patient information letter
Background information
Sinusthrombosis is caused by a clot in the veins, at the periphery of the brain, which causes an obstruction to the blood flow out of the brain. Because of this obstructed blood flow, certain functions of the brain can be affected. The standard treatment for this disease is giving a drug that temporarily inhibits clotting of the blood, such as heparin. With this treatment most patients with sinusthrombosis make a good recovery. However, your physician has diagnosed a severe kind of sinusthrombosis. This more severe form of sinusthrombosis may also recover completely, but the chances of full recovery are smaller.
Aim of the trial
The aim of the present clinical trial is to examine if the treatment of severe sinusthrombosis can be improved with a new method, called endovascular thrombolysis. This means that the blot clot is dissolved by means of a small tube (a catheter), which is introduced into the veins. However, there is no proof that this treatment is actually better, and there are also possible risks. The decision which treatment you get (standard treatment with heparin or endovascular thrombolysis) will be decided by “randomisation”. This means that a computer program decides which treatment is applied, based upon chance. The chance to get the new treatment is 50%.
Participating
If the outcome of the randomisation is “endovascular thrombolysis” this treatment will be applied. If the outcome of the randomisation is “standard treatment” than you will be treated with heparin.
Six months after the beginning of the sinusthrombosis you will be checked at the outpatients department. Here some questionnaires will be filled out to assess the deagree of recovery you have made. This will take no more than 15 minutes.
Some days before this outpatient assessment, a new CT or MRI scan of your brain will be made. This is the same examination which was used six months before to diagnose the sinusthrombosis.
One year after the beginning of the sinusthrombosis you will be assessed again at the outpatient department, using the same questionnaires. At this visit no new scan of the brain will be made.