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. |
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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to the piracetam. 3 people died, 1 from the treatment group, 2 from those receiving the placebo. 2 further people were withdrawn from the treatment group and one from the placebo group because of illness.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 |