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

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul St. Mary's Hospital
• Collaborator: Green Cross Corporation

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.