Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
The study aims to review the efficacy of intravenous magnesium as a treatment for acute stroke when compared to placebo. Pre-clinical animal models of acute stroke show that magnesium has similar effi
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed acute stroke with limb weakness 2. Symptoms present for at least 1 h and treatment initiation possible within 12 h of onset 3. Aged 18 or older 4. Previously independent in activities of daily living
Exclusion criteria
Exclusion criteria: 1. Co-existing disease likely to prevent outcome assessment. 2. Known chronic renal impairment. 3. Known intracerebral pathology other than stroke e.g. intracranial abscess, subarachnoid haemorrhage, brain tumour. 4. Known indication or contraindication for magnesium therapy. 5. Coma. 6. Concomitant experimental therapy. 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the proportion of patients dead or disabled at 90 days. Comparison between groups will be by intention to treat analysis. Disability will be measured by the Barthel Index. Patients scoring greater than or equal to 60 will be considered independent and those scoring less than 60 will be considered disabled. Patients who die will be allocated a Barthel score of 0. Overall mortality and disability by Rankin Score will also be carried out. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Australia, Canada, China, Singapore, United Kingdom, United States of America
Outcome results
None listed