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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Biological: Human Serum Albumin 20
* Drug: 0.9 % Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age less than 75 years old Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke 5 ≤ NIHSS score < 15 Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily Exclusion Criteria: Medical history of congestive heart failure or patients who are judged congestive heart failure on admission. Patients with cardiac edema or pulmonary edema. Medical history of myocardial infarction within the past six months. Patients who have serious aortic stenosis and mitral valve stenosis. Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L) Those Who had cardiac surgery. Onset of cerebral infarction within the past three months. Before onset of cerebral infarction, patients who were diagnosed as Historical mRS ≥ 2. Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis. Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission. Acute or chronic lung disease requiring supplemental O2 therapy on admission Severe anemia (Hb < 8.0) Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(>100/min), and oliguria) Fever, defined as core body temperature>37.5 ℃ Serum creatinine > 2.0 mg/dL History of allergy to albumin. Patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia) Pregnancy Patients who are in life-threatening or stupor coma situation. Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on admission CT or MRI scan. Patients who are not the normal, excesses of circulating blood. Haemolytic anemia, anemia due to blood loss. Immunodeficiency disease, immunosuppression. Blood pressure higher than 180/110 mmHg on admission.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human Serum Albumin 20<br>Human Serum Albumin 20% 100cc intravenously infused over 4 8h | Biological: Human Serum Albumin 20<br>* 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<br>* Other names: Human Serum Albumin Injection 20% 100ml Greencross;|
| Placebo Comparator: 0.9 % Normal saline<br>Treatment with same volume of normal saline | Drug: 0.9 % Normal Saline<br>* Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4 8h, commencing within 12 hours of stroke onset<br>* Other names: 0.9 % Normal Saline ChoongWae INJ. 100ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in NIHSS | Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h 0days) and 14±3days | at 14±3days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS Score | Comparison of NIHSS score between the control and ALbumin group at 14±3days | at 14±3days | 
| Proportion of patients with improvement by NIHSS | Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days. | at 14±3days | 
| modified Rankin Scale(mRS) favorable outcome | Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h 0days) and 3 months. | at 3 months | 
| Volume difference on diffusion MRI | Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days | at 4 days±1days | 
| Recurrent new ischemic lesions on diffusion MRI | Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI | at 4±1days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke, Albumin