Subarachnoid haemorrhage Circulatory System Subarachnoid haemorrhage
Conditions
Interventions
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 standa
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years 2. WFNS grade 4 or 5 SAH (grade for trial eligibility purposes is the WFNS grade recorded at first medical assessment following: hospital attendance AND confirmation of the diagnosis of SAH – by CT (or MRI) and/or lumbar puncture) 3. Assent obtained from next of kin, professional consultee or welfare attorney/nearest relative
Exclusion criteria
Exclusion criteria: 1.WFNS grade 1-3, or uncertain WFNS grade (where patient recovers quickly and proves not to be of true high grade): 1.1. Patients of uncertain grade on transfer to a neuroscience unit where a formal sedation hold is undertaken at the neurosciences centre and the patient is established to be truly grade 4 or 5 will be eligible for trial 1.2. This will also apply to patients of uncertain grade undergoing sedation hold after insertion of external ventricular drain (EVD) or other early intervention for hydrocephalus 2. Signs of coning or brain death not promptly reversed by anti-cerebral oedema treatment 3. Pure intraventricular haemorrhage (no SAH) 4. Large intracerebral haematoma which requires immediate clot evacuation 5. Significant aneurysmal SAH-related haemodynamic instability 6. Lack of clinical equipoise 7. Lack of assent/consent 8. Pregnancy 9. Pre SAH modified Rankin score >2 10. Pre-existing severe co-morbidity such that clinical follow up at 12 months is judged unlikely 11. Non-saccular, Mycotic, giant or other atypical aneurysm For MRI sub study only Known absolute contra indication to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome is measured by ordinal analysis of modified Rankin Score (mRS) at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Czech Republic, England, Estonia, Hungary, Latvia, Lithuania, Poland, United Kingdom
Contacts
Public ContactPhilip;Philippa White;Watts
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Outcome results
None listed