Study designs of evaluations included in the review
Randomised controlled trials (RCTs) were eligible for inclusion.
Specific interventions included in the review
Studies that compared defibrase with placebo, administered within 24 hours of symptom onset, were eligible for inclusion. It appears that both treatment groups had to use calcium-channel antagonists and dilatancy agents (excluding other fibrinogen agents, anticoagulants, thrombolysis agents or platelet aggregation inhibitors). In the included studies, treatment consisted of the administration of defibrase 10 to 15 U in 250 saline over 2 hours, followed by 5 U every other day for 2 or 4 occasions.
Participants included in the review
Studies of patients aged 35 to 75 years who had been diagnosed with acute cerebral infarction using criteria set up at the Fourth Cerebrovascular Diseases Conference in 1995 were eligible for inclusion. Myodynamia had to range from grade 0 to IV. Patients who were in a coma, suffered an epileptic seizure at stroke onset, had a blood glucose level less than 2 mmol /L or greater than 10 mmol/L, had previously suffered from intracranial haemorrhage, or suffered a stroke in the past 6 months, were not eligible.
Outcomes assessed in the review
Studies had to report the neurological deficit score (NDS), Barthel index, and numeration data including plasma fibrinogen level to be eligible for inclusion. The authors state the primary outcome measurement included NDS before treatment and at 2 weeks post-treatment, the Barthel Index at 3 months post-treatment, and plasma fibrinogen level before and after treatment.
How were decisions on the relevance of primary studies made?
Two reviewers independently selected studies for inclusion.