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


Phase 2 Results N/A

Eligibility Criteria

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.