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. 2001 Oct 23;2001(4):CD000424. doi: 10.1002/14651858.CD000424

Platt 1993.

Methods Clinically controlled double blind study. No details are available of the allocation procedure.
Participants As far as can be determined from the text, the setting was a single hospital in Germany. 56 people were admitted to the study, with an acute disturbance of the cerebral blood flow, aged 73‐84 years. 52% of the treatment group and 66% of the placebo group were male. 
 Inclusion criteria: 
 The event had occurred within preceding 3 days 
 Stenosis of internal carotid or intracranial arteries 
 Aged more than 56 years 
 Acute supratentorial first cerebral ischaemia confirmed by a CT scan 
 Exclusion criteria: 
 Contra indication of hypervolemic hemodilution. 
 Acute myocardial infarction 
 Severe cardiac insufficiency 
 Severe renal insufficiency 
 Malignant hypertension 
 Polyglobulism 
 Hemorrhagic diathesis 
 Hemorrhagic infarct, cerebral hemorrhage 
 Cerebral oedema confirmed by CT 
 Disturbance of blood brain barrier 
 Reinfarction 
 Repeated TIAs or PRIND attacks 
 Progressive cerebral degeneration 
 Insulin dependant diabetes 
 Malignancy 
 Systemic disease
Interventions Once daily fast infusion (20 mins) of 12 g piracetam versus saline as placebo. 27 were treated with piracetam, 29 with placebo, for 14 days. 
 From day 15 people in the treatment group were given 2x800mg piracetam 3 times a day, those in the control group were given placebo tablets.
A background therapy of 500mls HAES/200 10% was administered in 4 hours plus low dose heparin with 15000 U/day over the entire period of the study.
Outcomes Participants were assessed on a 4 point scale of language function. The authors report that a statistically significant difference was found in favour of the treatment group regarding aphasia and all other parameters tested, except sensitivity to the piracetam. 
 3 people died, 1 from the treatment group, 2 from those receiving the placebo. 2 further people were withdrawn from the treatment group and one from the placebo group because of illness. All these people were considered therapeutic failures for the statistical analysis. Authors reported that they did not believe there to have been any unwanted effects found during the trial. All the remaining 50 participants completed the 4 week period of the study.
Notes No explicit mention was made in the report about whether the placebo tablets looked and tasted like piracetam tablets.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear