Subarachnoid haemorrhage Circulatory System Subarachnoid haemorrhage
Conditions
Interventions
Simvastatin versus placebo
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65 years 2. If the admitting neurosurgeon has a high index of suspicion of a spontaneous aneurysmal subarachnoid haemorrhage (good clinical history with convincing computerised tomography [CT] findings) 3. Any clinical grade accepted provided there is a reasonable prospect of survival 4. Delay to randomisation and initiation of trial medication, from the time of the presenting bleed, does not exceed 96 hours 5. Independent prior to the SAH
Exclusion criteria
Exclusion criteria: 1. Unsalvageable patients: fixed and dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy 2. Already taking statin therapy 3. Those taking warfarin-type drugs 4. Pregnancy 5. Known renal or hepatic impairment 6. Suspected or known additional disease process, which threatens life expectancy (e.g. malignancy) 7. Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to six-month follow up
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Short form questionnaire (SF-36) scores at six months 2. Incidence and duration of delayed ischaemic deficits 3. Need and intensity of delayed ischaemic deficits rescue therapy 4. Incidence of extracranial organ dysfunction and failure 5. Incidence and duration of extracranial organ support 6. Incidence and severity of sepsis 7. Length of intensive care and total acute hospital stay 8. Percentage of patients being discharged directly home 9. Reduction in intensive care requirements for those with sepsis | — |
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome at six months | — |
Countries
United Kingdom
Outcome results
None listed