Treatment of Subarachnoid Hemorrhage With Human Albumin
The purpose of this study is to evaluate the tolerability and safety of 25 percent human albumin therapy in patients with subarachnoid hemorrhage.
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 lining of the brain. SAH is associated with a 51percent mortality rate, and one third of survivors are left functionally dependent. Cerebral vasospasm, which is a delayed narrowing of the cerebral arteries following SAH, has been identified as the most important reason for neurological deterioration and bad outcome in cases of SAH. Cerebral vasospasm may be caused by multiple mechanisms.
Treatment with a neuroprotective agent, such as human albumin (HA), may be beneficial for prevention of cerebral vasospasm and improved clinical outcome in patients with SAH. HA is a major protein found in blood and is responsible for maintaining fluid balance in the vascular system (blood vessels). The purpose of this study is to determine the safety and tolerability of 25 percent HA therapy in patients with SAH. This open-label, dose-escalation study will provide necessary information for a future definitive phase III clinical trial on the efficacy of treatment with HA in patients with SAH.
The study will enroll 80 patients at 5 centers in the US. Patients with eligible SAH will first undergo surgical or endovascular repair, which is considered standard care. Endovascular repair is a repair of the aneurysm from the inside of the blood vessel.
Following neurosurgical or endovascular treatment, participants will be given a daily infusion of HA for 7 days. The HA dose will be allocated as follows: the first tier (20 patients) will receive 0.625 grams (g) of HA per kilogram (kg) of body weight; patients in the second tier will receive 1.25g of HA per kg; patients in the third tier will receive 1.875g of HA per kg; and patients in the fourth tier will receive 2.5g of HA per kg. Safety and tolerability will be evaluated by the Data and Safety Monitoring Board (DSMB) after each tier is completed and before the study advances to the next dose tier. A specific safety threshold for congestive heart failure and other adverse events has been defined based on data from previous studies.
In the follow-up phase, patients will participate in study-related evaluations of their health at 15 days and three months. Duration of the study for participants is 90 days.
Allocation: Non-Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The Johns Hopkins Hospital
Baylor College of Medicine
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00283400
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status.
A condition in which albumin level in blood (SERUM ALBUMIN) is below the normal range. Hypoalbuminemia may be due to decreased hepatic albumin synthesis, increased albumin catabolism, altered albumin distribution, or albumin loss through the urine (ALBUMINURIA).
Bleeding into the SUBARACHNOID SPACE due to CRANIOCEREBRAL TRAUMA. Minor hemorrhages may be asymptomatic; moderate to severe hemorrhages may be associated with INTRACRANIAL HYPERTENSION and VASOSPASM, INTRACRANIAL.
Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)
Normal human serum albumin mildly iodinated with radioactive iodine (131-I) which has a half-life of 8 days, and emits beta and gamma rays. It is used as a diagnostic aid in blood volume determination. (from Merck Index, 11th ed)
To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.
The purpose of this study is to determine if giving blood transfusions to anemic patients with subarachnoid hemorrhage will reduce their chances of having a stroke from vasospasm.
Extensive research has shown that the big event that leads to the initiation of vasospasm is the release of oxyhemoglobin (blood breakdown product).Depletion of NO synthase (19,20,21) was...
The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently app...
Our primary objective is to compare two treatment options for prevention of seizures following a subarachnoid hemorrhage and determine if a short-course regimen of levetiracetam is as effi...
Subarachnoid hemorrhage (SAH) is a devastating disease. Nimodipine is the only medical treatment shown to improve outcome of SAH patients. Human albumin (ALB) may exert neuroprotection in SAH. However...
Spinal subarachnoid hemorrhage has many causes including trauma, vascular malformations, aneurysms, spinal cord tumors, coagulation abnormalities, use of anticoagulants, systemic lupus erythematosus,...
Objective To assess trends in mortality from 1999 to 2008 resulting from non-traumatic subarachnoid hemorrhage (SAH) in the Colombian population. Method This population-based study analyzed all deaths...
Cardiac manifestations of intracranial subarachnoid hemorrhage patients include mild electrocardiogram variability, reversible left ventricular dysfunction (Takotsubo), non-ST elevation myocardial inf...
Approximately 15% of patients with non-traumatic subarachnoid hemorrhage have no causative lesion identified on their initial angiogram. We present two patients with non-traumatic subarachnoid hemorrh...