Cerebral Infarction Clinical Trial
Official title:
A Phase IIB Placebo Comparative, Double Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of ALbumin Therapy in Acute Ischemic Stroke Patients in Korea.
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.
According to the statistics of the cause of death in 2008 by the Statistics Korea, the
stroke was accounted for a large proportion of cause of death among adults, as well as
higher mortality, severe sequelae. These stroke in acute phase showed neurological
deterioration over 50% of the patients after beginning of treatment and the sequelae
resulting in that the nervous tissue was not regenerated is regarded as irreversible
changes.
The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body
weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount
of placebo (saline solution (0.9% normal saline)) administered to the control group will be
compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic
stroke.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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