The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke "ALbumin"

Terminated

Phase 2 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

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