Status:
TERMINATED
Treatment of Subarachnoid Hemorrhage With Human Albumin
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.
Detailed Description
An estimated 37,500 people in the United States have subarachnoid hemorrhage (SAH) every year. SAH is usually secondary to a brain aneurysm that has burst. In SAH the bleeding accumulates around the l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00283400
Start Date
January 1 2006
End Date
April 1 2011
Last Update
April 1 2015
Active Locations (6)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Penn State University
Hershey, Pennsylvania, United States, 17033
3
Data Coordination Unit, Department of Biostatistics, Bioinformatics and Epidemiology, at the Medical University of South Carolina
Charleston, South Carolina, United States, 29425
4
Baylor College of Medicine
Houston, Texas, United States, 77030