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What is the TOPSAT2 study about?

Subarachnoid haemorrhage (SAH) is a form of stroke where there is a bleed on the surface of the brain.  SAH is usually caused by weaknesses in a brain artery called an aneurysm.  Recovery often depends on the severity of the brain injury.  The initial condition after SAH is assessed by the WFNS (World Federation of Neurosurgical Societies) grading system.  Patients in WFNS grades 1-3 often recover well, but patients with high WFNS grade (4-5) may end up with a bad outcome such as death or severe disability.

Grade 1-3 patients are usually treated early based on high quality evidence from studies.  However, there is no good evidence-base for deciding on the timing of management of grade 4-5 SAH.  There are currently two strategies for treating such patients; early treatment (within 24 hours of admission) or treatment after neurological recovery.  There may be increased risks with early treatment but there are potentially risks with delaying treatment as well.  Both are standard approaches, but the TOPSAT2 study aims to find out whether one has a better outcome than the other.  Patients in the study are allocated at random to either the early treatment arm (aneurysm treatment is performed within 24h of enrolment) or the conventional management arm, (treatment is carried out after the patient makes a satisfactory neurological recovery), to find out which approach is better.  In some hospitals, we will also perform brain (MRI) scans to see if they help predict recovery.

At 6 and 12 months after the haemorrhage occurred, we will ask participants to complete a questionnaire which determines how well people are able to cope with activities of daily life.  Given that there is a lack of evidence on how best to treat grade 4-5 patients, this is an important study from which we hope to collect the necessary data to improve the treatment of this disease.