| Methods |
Randomised.
Concealment: predetermined random order.
Double‐blind.
19 patients exluded from the analysis.
Non intention to treat. |
| Participants |
Probable ischaemic stroke in the carotid artery territory with hemiparesis.
Excluded: probable brainstem stroke, TIA, residual deficit from previous strokes, other major neurological disorder and patients treatable with anticoagulants and other presumed to be effective. Renal, hepatic and cardiac failure.
192 cases randomised (19 excluded from the analysis)
F = 107, M = 66.
Range 67 to 96 years; mean age 78.4 years.
Any severity considered but imminent death.
Time entry window < 48hours. |
| Interventions |
Glycerol 10% i.v. in 500 ml saline vs 500 ml saline over 4 hours for 6 days. |
| Outcomes |
Death at 7 days and 3 months and 1 year.
Disability/handicap scale (Rankin scale) at 3 months and 1 year.
Length of hospital stay. |
| Notes |
19 excluded from the analysis: 11 had exclusion criteria after randomisation, 2 out of time window and 6 treated with not considered drugs.
Lumbar puncture ?%, Allen score in half of the trial,
CT‐scan only when in doubt of diagnosis: 42 out 173. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |