Treatment of Poor Grade Subarachnoid Haemorrhage Trial 2
What is the TOPSAT2 study about?
The aim of this study is to establish the efficacy of a strategy of early aneurysm treatment (within 72h of ictus) in a population of World Federation of Neurosurgical Societies grade 4-5 (high grade) aneurysmal subarachnoid haemorrhage (aSAH) patients in comparison with the conventional strategy of treatment of aneurysm after neurological improvement (to WFNS grade 1-3).
Participants will be followed up for a total period of 12 months within the trial site that patients were admitted to until day 30 or discharge (whichever is the sooner), and then at 6 and 12 months later by way of postal or online mRS and EQ5D questionnaires completed by the participants.
Primary Outcome Measures
Secondary Outcome Measures
2. Mortality rate is measured by -survival analysis at 30 days, six months and 12 months
3. Re-bleeding rate is measured by the number of re-bleeds that have occurred at 12 months
4. Treatment related complication rate & SAE report rates are measured by the number of treatment related complications and SAEs that have occurred at 12 months
5. Time to hospital discharge is measured by length of time in hospital from randomisation at discharge date
6. Length of ITU/HDU stay is measured by length of time in ITU/HDU from randomisation at discharge date
7. Functional outcome is measured by ordinal analysis of modified Rankin Score (mRS) at 6 months