| Methods |
Multicentre, double‐blind, placebo‐controlled
Randomisation by secure Internet central randomisation (with block size of 6)
ITT analysis |
| Participants |
UK
172 patients: T: 56, C: 29
Mean age: 74 years
Male 57%
Inclusion: > 18 years of age, fixed neurological deficit > 60 minutes, clinical diagnosis of acute stroke
Enrolment within 36 hours of ictus |
| Interventions |
Labetalol 50 mg po or matching placebo was initially given with the opportunity to repeat this at 4 hours and 8 hours after randomisation
Thereafter patients were continued on 50 to 150 mg of labetalol twice daily for 2 weeks, including for dysphagic patients (after 72 hours intravenous labetalol was converted to oral or nasogastric labetalol depending on swallowing status in dysphagic patients) |
| Outcomes |
Death or dependency at 2 weeks
Supine BP was measured with a validated A&D UA‐767 BP monitor with a cuff of a suitable size |
| Notes |
Ex: hypertensive encephalopathy, co‐existing cardiac or vascular emergency, SBP > 200 mmHg and/or DBP > 120 mmHg in association with primary intracerebral haemorrhage, pre‐existing antihypertensive therapy in patients without dysphagia, impaired level of consciousness, contraindication to trial therapy, premorbid mRS > 3, coexisting life threatening condition with life expectancy < 6 months, diagnosis of non‐stroke on subsequent neuroimaging |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomly assigned by secure Internet central randomisation (with a block size of 6) |
| Allocation concealment? |
Low risk |
Probably done |
| Blinding? |
Low risk |
Probably done |
| Completeness of follow‐up |
High risk |
179 patients randomly assigned, 6 withdrawn due to a protocol violation or non‐stroke diagnosis and 1 withdrew consent |
