Albumin in Acute Stroke "ALIAS - Pilot"


Phase N/A Results

Eligibility Criteria

Inclusion Criteria

Patients with a history of a focal neurologic syndrome of acute onset and at least a moderate initial neurologic deficit, defined as an NIHSS score of 6 or greater; computed tomography (CT) or magnetic resonance scan excluding hemorrhage; ability to commence the intravenous infusion of 25% ALB within 16 hours after the onset of stroke symptoms (defined as the time at which the onset of a neurologic abnormality was observed or, with symptoms first noticed on awakening from sleep, the last time the patient was observed to be without stroke symptoms).

Exclusion Criteria

History and/or physical findings on admission of congestive heart failure (CHF), including jugular venous distention, third heart sound, resting tachycardia >100/min attributable to heart failure, hepatomegaly, and/or lower extremity edema attributable to heart failure or without apparent cause. (Initially, the historical CHF exclusion pertained to the preceding 6 months; this was later changed to “at any time in the past.”)Hospitalization for acute myocardial infarction within the preceding 3 months.Symptoms or electrocardiographic (ECG) signs of acute myocardial infarction on admission.ECG findings and/or history or physical findings of second- or third-degree heart block or of cardiac arrhythmia associated with hemodynamic instability (in theinvestigator’s judgment).[In year 1:] admission two-dimensional echocardiographic findings of: (1) ejection fraction less than 40%; (2) moderate or severe valvular stenosis or severevalvular insufficiency; (3) right ventricular systolic pressure 50 mm Hg; or (4) diastolic dysfunction. [In year 2, these exclusions were dropped; instead, anechocardiogram was merely obtained within the first 24 hours.]Acute or chronic renal failure (serum creatinine >2.0 mg/dL)Severe anemia (hematocrit <32%)Clinically suspected aortic dissectionPresenting symptoms and/or CT scan evidence of subarachnoid hemorrhageParenchymal intracerebral hemorrhage on pretreatment CT scanPregnancy in women aged 18 to 55 (pregnancy test required in women of childbearing age unless known to be surgically sterilized or postmenopausal)History of allergic reaction to ALB administrationBlood pressure higher than 185/110 mm Hg at the time of ALB administrationOther active, potentially life-threatening disordersSubjects receiving intravenous tPA were required as well to satisfy the tPA exclusion criteria used in the NINDS tPA trial19Additional exclusion criteria introduced in January 2004 (applicable to the last 30 subjects)Known valvular heart disease requiring medical therapyProsthetic heart valvesAny current chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, past lung resection, and other lung disease that interfereswith daily activities.