| Methods |
Randomised.
Concealment: according to stratified randomised block design.
Double blind.
19 patients lost to follow up.
Intention to treat. |
| Participants |
Spontaneous supratentorial heamorrhage.
Excluded: previous history of stroke, posterior fossa haemorrhage or due to aneurysm or arteriovenous malformations or conditions warranting neurosurgery. Collagen vascular diseases, bleeding diathesis, anticoagulant therapy.
216 patients,
F = 78, M = 138.
Mean age 64 years. Any severity considered.
Time entry window: within 45 hours from the onset. |
| Interventions |
Glycerol 10% i.v. in 500 ml saline vs 500 ml saline over 4hours for 6 days |
| Outcomes |
Death at 6 days and 6 months.
Neurological score system (Scoring System of the Scandinavian Stroke Study group). Glasgow Coma Scale and Barthel Index (data not available for 17 glycerol and 13 control patients). Side effects of treatment. |
| Notes |
CT scan in all patients. 19 lost to follow up: 10 glycerol + 9 control group.
9 patients in glycerol and 2 in control group withdrawn treatment due to side effects, considered in the analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
