TOPSAT2
Research type
Research Study
Full title
Treatment Of Poor-Grade Subarachnoid Haemorrhage Trial 2
IRAS ID
197040
Contact name
Philip White
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN15960635
Clinicaltrials.gov Identifier
BH number, BH136441
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Subarachnoid haemorrhage (SAH) is a form of stroke where there is a bleed on the surface of the brain. Unlike most strokes (due to an artery blockage), SAH mainly affects relatively young people (aged 40-60). SAH is usually caused by weaknesses in brain arteries called aneurysms. Recovery largely depends on the severity of the brain injury and is assessed by the WFNS (World Federation of Neurosurgical Societies) grading system. Patients with WFNS grade 1-3 usually recover well, but patients with high WFNS grade (4-5) often end up with a bad outcome such as death or severe disability. \nGrade 1-3 patients are treated early, based on high quality evidence from studies. However, there is no good evidence-base for deciding on the management of grade 4-5 SAH. There are currently two strategies for treating these patients; early treatment or treatment after neurological recovery. If assent is given (by a relative or independent senior doctor, since the patient will not be able to consent for themselves), a patient will be randomly allocated to either the early treatment arm (aneurysm treatment will be 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. We will also perform brain MRI scans in a subgroup of centres/patients to see if they help predict recovery.\n\nOutcome will be measured after 12 months using a questionnaire which determines how well people are able to cope with activities of daily life. Brain scans will be analysed to determine if they can be used to predict patient outcome from the outset. Given that there is a lack of evidence on how best to treat grade 4-5 patients we aim to provide the necessary data to improve the treatment of this disease.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0234
Date of REC Opinion
20 Jun 2016
REC opinion
Favourable Opinion