Methods |
Single centre, double‐blind, placebo‐controlled
Randomisation technique not stated
PP analysis
FU: 4 lost |
Participants |
German
44 participants: T: 24, C: 20
Mean age: T: 59 years, C: 54 years
Males: T: 17, C:10
Inclusion: IS diagnosed on neurological examination and 100% CT, first stroke
Enrolment within 5 days
Proof of vascular stenoses or occlusions of the supplying or intracranial brain vessels by means of doppler sonography or cerebral angiography |
Interventions |
T and C: continuous iv of 1000 ml Dextran 40 plus 2 x 150 ml Sorbit 40% daily during the first 3 days
T and C: over 4 to 6 hours a daily infusion of 500 ml Dextran 40 from day 4 to day 14
T: 3 x 4 g/20 ml piracetam iv bolus day 1 to day 14; FU 28 days
C: matching placebo
T: 4.8 g piracetam po daily for following 14 days
C: matching placebo po daily for following 14 days |
Outcomes |
Neurological and psychiatric assessments using own scales at baseline and days 7, 14, 28
Organic brain psychosyndrome was determined using Lehrl and Erizgkeit short syndrome test
Method of measuring BP not known |
Notes |
Ex: patients with severe internal disease (heart and lung disease), liver or renal insufficiency, DM, fixed hypertonia, neoplasia, hematological and systemic diseases, patients who had earlier neurological diseases of a different nature, drug or alcohol abuse
4 patients were lost to follow up for following reasons: cardiac insufficiency, cardiac infarctus, pneumonia, gastrointestinal bleeding (T:1, C:3) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Probably done |
Allocation concealment? |
Unclear risk |
Unclear from the publication |
Blinding? |
Low risk |
Probably done |
Completeness of follow‐up |
High risk |
4 lost to follow up |