Treatment of Subarachnoid Hemorrhage With Human Albumin

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.