Treatment of Subarachnoid Hemorrhage With Human Albumin (ALISAH)

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring subarachnoid hemorrhage Read More

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.