Femme et Homme
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Extrait
Background and study aims A subarachnoid haemorrhage (SAH) is a type of stroke that is most often caused by a bulge in a brain blood vessel (aneurysm) bursting and bleeding into the subarachnoid space surrounding the brain. It is a life-threatening disease and those patients who survive the early bleeding are at risk of developing secondary complications such as delayed cerebral ischemia (DCI), a form of secondary stroke. In general, DCI is the major cause of poor outcome and death after SAH. One of the major contributors to DCI is the amount of blood in the subarachnoid space, and reducing the subarachnoid blood has been found to decrease DCI. Therefore the aim of this study is to assess the effect of blood clearance using a blood resolving agent (rt-PA) in patients with severe aneurysmal SAH. Who can participate? Patients aged over 18 with severe aneurysmal SAH What does the study involve? Participants are randomly allocated to one of two groups. One group is treated with rt-PA via a standard monitoring catheter (tube) into the brain chambers (ventricles) whilst being slowly rotated on a moving bed for 48 hours. The other group receives treatment as usual. Both groups are followed up to assess their neurological (mental) outcome and undergo CT scans to check for cerebral infarctions (brain damage). What are the possible benefits and risks of participating? By reducing the amount of blood in the subarachnoid space, DCI and poor neurological outcome may be prevented. One possible risk of rt-PA is an increased risk of bleeding in the brain (intracranial) or in the rest of the body (systemic). However, based on previous studies, the risk of side effects is very low. Where is the study run from? Heinrich-Heine University (Germany) When is the study starting and how long is it expected to run for? December 2008 to September 2011 Who is funding the study? Heinrich-Heine University (Germany) Who is the main contact? Prof. Daniel Hänggi
Critère d'inclusion
- Aneurysmal subarchnoid hemorrhage