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. 2004 Apr 19;2004(2):CD000096. doi: 10.1002/14651858.CD000096.pub2

Azzimondi.

Methods From 07/1994 to 06/1997. 
 Randomised. 
 Adequate allocation concealment. 
 Outcome assesment blind. 
 3 patients excluded from the analysis and 3 patients lost to follow‐up. 
 Intention to treat.
Participants First ever ischaemic stroke in the carotid artery territory with impairment of conscioussness. Excluded: deep and depassè coma according to Bricolo's (1975) classification. Hemorrhagic, vertebrobasilar and lacunar stroke; impaired conscioussness due to causes other than stroke; renal hepatic and cardiac failure. 
 67 cases randomised, 
 F = 38, M = 29. 
 Mean age 75 years. 
 Time entry window: 12 hours.
Interventions Glycerol 10% i.v. in 500 ml in over 4 hours vs glycerol 10% i.v. in 500 ml b.i.d. vs avoid glycerol.
Outcomes Death at 7, 30 days, 6 and 12 months. Disability (Barthel index) and disability/handicap (modified Rankin Scale) at 6 and 12 months. 
 Side effects of treatment.
Notes Not published. No data available for 3 randomised patients. 1 patient in avoid glycerol, 2 patients in glycerol low dose lost at follow‐up. 
 Low and high doses of glycerol considered together.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate