Albumin in Acute Ischemic Stroke Trial

Exclusion Criteria

• •Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization.
• •Known valvular heart disease with CHF in the last 6 months.
• •Severe aortic stenosis or mitral stenosis.
• •Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months.
• •Acute myocardial infarction in the last 6 months.
• •Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
• •Baseline elevated serum troponin level on admission (\>0.1 mcg/L)
• •Suspicion of aortic dissection on admission.
• •Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability.
• •Findings on physical examination of any of the following: (1) jugular venous distention (JVP \> 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate \> 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure; and/or (6) definite chest x-ray evidence of pulmonary edema.
• •Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
• •In-patient stroke. I.e., patients with a stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
• •Planned acute use of intra-arterial (IA) tPA or acute endovascular intervention (e.g., stenting, angioplasty, thrombus retrieval device use) must conform to the following criteria: (1) begin within 5 hours of symptom onset, and (2) finish within 7 hours of symptom-onset.
• •Fever, defined as core body temperature \> 37.5° C (99.5°F).
• •Serum creatinine \> 2.0 mg/dL or 180 µmol/L.
• •Profound dehydration.
• •Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
• •History of allergy to albumin.
• •History of latex rubber allergy.
• •Severe chronic anemia with Hgb \< 7.5 g/dL
• •Pregnancy, breastfeeding or positive pregnancy test. (Women of childbearing age must have a negative pregnancy test prior to ALB administration.)
• •Concurrent participation in any other therapeutic clinical trial.
• •Evidence of any other major life-threatening or serious medical condition that would prevent completion of 3-month follow-up, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.