Bath 2001.
Methods | Double‐blind, placebo‐controlled Randomisation by computer (minimisation by age, mean arterial BP, baseline SSS, hours from onset, presence of stroke lesion on CT) |
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Participants | UK, single centre 37 participants: treatment 16; control 21 Age: treatment 76 years; control 72 years Male: treatment 6 (38%); control; 12 (57%) Inclusion: IS or ICH Time to randomisation: within five days of onset |
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Interventions | Treatment: transdermal GTN patch 5 mg once daily
Control: matching placebo Duration: 12 days |
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Outcomes | Primary: BP on day 1 (24 hour ambulatory BP measured 3 times per hour during the day and hourly at night at days 0, 1, 8) Secondary: death at end of treatment; death or dependency (mRS > 2), death, and BI at 3 months | |
Notes | Exclusion: taking part in another trial | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer randomisation with minimisation |
Allocation concealment (selection bias) | Low risk | Computer randomisation with minimisation |
Blinding (performance bias and detection bias) All outcomes | Low risk | Matching treatment and placebo patches |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Matching treatment and placebo patches |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessed blinded to treatment group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No differences between trial groups |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Low risk | None found |