Treatment of Subarachnoid Hemorrhage With Human Albumin

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)

Criteria

Inclusion Criteria:

• Patients (male or female) were 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.

• Computed tomography demonstrated subarachnoid hemorrhage.

• Cerebral angiography revealed the presence of saccular aneurysm(s) in a location that explains the subarachnoid hemorrhage.

• Treatment of cerebral aneurysm was carried out prior to initiation of HA infusion but within 72 hours of symptom onset. Accepted treatments of aneurysms include surgical clipping or endovascular embolization.

Exclusion Criteria:

• Time of symptom onset could 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

• Computed tomography scale of 0-1

• History within the past 6 months, and/or physical findings on admission of decompensated congestive heart failure (NYHA Class IV or congestive heart failure requiring hospitalization).

• Patient 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 ≤ 40% (if available).

• Serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min.

• Pregnancy, lactation or parturition within previous 30 days.

• Allergy to albumin.

• Severe prior physical disability that precludes evaluation of clinical outcome measures.

• History of chronic lung disease

• Current participation in another drug treatment protocol.

• Severe terminal disease with life expectancy less than 6 months.