A placebo comparative, double blinded, randomized, multicenter study to evaluate the efficacy and safety of albumin therapy in acute ischemic stroke patients in Korea
- Conditions
- Diseases of the nervous system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 56
1. At least 18 years of age less than 75 years old
2. Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke
3. 5 = NIHSS score < 15
4. Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily
1.Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.
2.Patients with cardiac edema or pulmonary edema.
3.Medical history of myocardial infarction within the past six months.
4.Patients who have serious aortic stenosis and mitral valve stenosis.
5.Signs or symptoms of acute MI on admission (Serum troponin level =0.1 ug/L).
6.Those Who had cardiac surgery.
7.Onset of cerebral infarction within the past three months.
8.Before onset of cerebral infarction, patients who were diagnosed as Historical mRS = 2.
9.Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis.
10.Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.
11.Acute or chronic lung disease requiring supplemental O2 therapy on admission.
12.Severe anemia (Hb < 8.0).
13.Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(>100/min), and oliguria).
14.Fever, defined as core body temperature>37.5 ?.
15.Serum creatinine > 2.0 mg/dL.
16.History of allergy to albumin.
17.Patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia).
18.Pregnancy.
19.Patients who are in life-threatening or stupor coma situation.
20.Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on admission CT or MRI scan.
21.Patients who are not the normal, excesses of circulating blood.
22.Hemolytic anemia, anemia due to blood loss.
23.Immunodeficiency disease, immunosuppression.
24.Blood pressure higher than 180/110 mmHg on admission.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days
- Secondary Outcome Measures
Name Time Method Comparison of NIHSS score between the control and ALbumin group at 14±3days;Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days;Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months;Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days;Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI