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).

Study Design
Multi-centre prospective randomised controlled trial
Study Type
Interventional
Intervention
Participants are randomised to undergo either endovascular (coiling) or neurosurgical (clipping) treatment for their aneurysm within 24 hours of ictus or upon neurological improvement. Both are standard procedures and are performed whether or not they are in the study. At the time of enrolment all patients will be unconscious and therefore unable to consent, and so REC/HRA approval for assent has been sought. There are no further treatments and no study bloods are being taken.

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.

Intervention Type
Procedure/Surgery
Primary Outcome Measures
Functional outcome is measured by ordinal analysis of modified Rankin Score (mRS) at 12 months.
Secondary Outcome Measures
1. mRS is measured by dichotomisation of scores 0-3 (no or significant symptoms) vs 4-6 (severe symptoms and mortality) and 0-2 (no or few symptoms) v 3-6 (significant symptoms and mortality) at 12 months
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