NCT01684462

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

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Cerebral Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Human Serum Albumin 20	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
DRUG	0.9 % Normal Saline	Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4\~8h, commencing within 12 hours of stroke onset

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-09-13
• Last updated: 2013-12-02

Locations

4 sites across 1 country: South Korea