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.
- Human Serum Albumin 20 Biological
Other Names: Human Serum Albumin Injection 20% 100ml Greencross Intervention Desc: Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset ARM 1: Kind: Experimental Label: Human Serum Albumin 20 Description: Human Serum Albumin 20% 100cc intravenously infused over 4~8h
- 0.9 % Normal Saline Drug
Other Names: 0.9 % Normal Saline ChoongWae INJ. 100ml Intervention Desc: Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset ARM 1: Kind: Experimental Label: 0.9 % Normal saline Description: Treatment with same volume of normal saline
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Average change in NIHSS||at 14±3days||Yes|
|Secondary||NIHSS Score||at 14±3days||Yes|
|Secondary||Proportion of patients with improvement by NIHSS||at 14±3days||Yes|
|Secondary||mRS favorable outcome||at 3 months||Yes|
|Secondary||Volume difference on diffusion MRI||at 4 days±1days||Yes|
|Secondary||Recurrent new ischemic lesions on diffusion MRI||at 4±1days||Yes|
|Secondary||modified Rankin Scale(mRS) favorable outcome||at 3 months||Yes|