Treatment of Subarachnoid Hemorrhage With Human Albumin

20:04 EDT 21st October 2014 | BioPortfolio

Summary

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

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 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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Subarachnoid Hemorrhage

Intervention

human albumin

Location

The Johns Hopkins Hospital
Baltimore
Maryland
United States
21287

Status

Recruiting

Source

Baylor College of Medicine

Results (where available)

View Results

Links

Clinical Trials [321 Associated Clinical Trials listed on BioPortfolio]

A Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin on Subarachnoid Hemorrhage-Induced Vasospasm

To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.

Effect of Red Blood Cell Transfusion on Brain Metabolism in Patients With Subarachnoid Hemorrhage

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.

The Factors Cause Vasospasm After Aneurysmal Subarachnoid Hemorrhage

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 ...

Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

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...

Comparison of Short Duration Levetiracetam to Extended Course for Seizure Prophylaxis After Subarachnoid Hemorrhage (SAH)

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...

PubMed Articles [11010 Associated PubMed Articles listed on BioPortfolio]

Nonaneurysmal subarachnoid hemorrhage and cerebral infarction associated with moyamoya disease.

Moyamoya disease patients with subarachnoid hemorrhage and cerebral infarction are rare, especially when the subarachnoid hemorrhage is nonaneurysmal. Here, we present one 48-year-old male patient wit...

Repeated neurovascular imaging in subarachnoid hemorrhage when initial studies are negative.

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...

Terson syndrome in subarachnoid hemorrhage, intracerebral hemorrhage, and traumatic brain injury.

This prospective trial was designed to evaluate the incidence of Terson syndrome in patients suffering from subarachnoid hemorrhage, intracerebral hemorrhage, or traumatic brain injury and whether con...

Intraventricular Tissue Plasminogen Activator in Subarachnoid Hemorrhage Patients: A Prospective, Randomized, Placebo-Controlled Pilot Trial.

The quantity of subarachnoid (SAH) and intraventricular hemorrhage (IVH) occurring in the setting of a ruptured cerebral aneurysm is strongly associated with subsequent complications and poor outcomes...

Hospital Case Volume is Associated With Mortality in Patients Hospitalized With Subarachnoid Hemorrhage.

Prior studies have suggested hospital case volume may be associated with improved outcomes after subarachnoid hemorrhage (SAH), but contemporary national data are limited.

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)

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