ALISAHTreatment of Subarachnoid Hemorrhage With Human Albumin

Date de début de l'étude : 1 juin 2006

Inclusion Criteria: * Patients (male or female) must be at least 18 but younger than 80 years of age. * Onset of new neurological signs of subarachnoid hemorrhage within 72 hours at the time of evaluation and initiation of treatment with 25% human albumin. * Clinical signs consistent with the diagnosis of subarachnoid hemorrhage including severe thunderclap headache, cranial nerve abnormalities, decreased level of consciousness, meningismus and focal neurological deficits. * Head computed tomography demonstrates subarachnoid hemorrhage (rating scale 2-4). * Cerebral angiography reveals the presence of saccular aneurysm(s) in a location that explains the subarachnoid hemorrhage. * Treatment of cerebral aneurysm must be carried out prior to treatment initiation but within 72 hours of symptom onset. Accepted treatments of aneurysms include surgical clipping or endovascular embolization. * Signed and dated informed written consent by the subject or his/her legally authorized representative. Exclusion Criteria: * Time of symptom onset cannot be reliably assessed. * No demonstrable aneurysm by cerebral angiography. * Evidence of traumatic, mycotic, or fusiform aneurysm by cerebral angiography. * World Federation of Neurological Surgeons scale of IV and V * Head computed tomography rating scale of 0 - 1 * History within the past 6 months, and/or physical findings on admission of decompensated heart failure (NYHA Class III and IV or heart failure requiring hospitalization). * Patient has received albumin prior to treatment assignment during the present admission. * Hospitalization for or diagnosis of acute myocardial infarction within the preceding 3 months. * Symptoms or electrocardiographic signs indicative of acute myocardial infarction on admission. * Electrocardiographic evidence and/or physical findings compatible with second- or third-degree heart block, or of cardiac arrhythmia associated with hemodynamic instability. * Echocardiogram performed before treatment revealing a left ventricular ejection fraction \> or = 40% (if available). * Serum creatinine \> 2.0 mg/dl or creatinine clearance \< 50 ml/min. * Pregnancy, lactation or parturition within previous 30 days. * Known allergy to albumin. * Severe prior physical disability (Rankin Scale \> 2) that precludes evaluation of clinical outcome measures. * History of severe chronic obstructive lung disease (FEV1 \< 50% predicted, increased shortness of breath, and repeated exacerbations which have an impact on patients' quality of life). * History of confirmed or suspected liver failure (increased prothrombin time, elevated liver enzymes, hypoalbuminemia, and hyperbilirrubinemia with or without peripheral edema and encephalopathy) * Current participation in another drug treatment protocol. * Severe terminal disease with life expectancy less than 6 months.