Track topics on Twitter Track topics that are important to you
The purpose of this study is to find out what effects, good and bad, the medication Albumin has on subjects who have experienced a type of stroke known as an intracerebral hemorrhage (ICH). An ICH is when spontaneous bleeding into the brain occurs due to fragile blood vessels.
This research is being done because currently there is no effective treatment for ICH. However, study investigators believe that Albumin, the medication being tested in this study, is safe and may help improve patient recovery from ICH over time.
Subjects will be enrolled in the study for a total of 90 days. Following enrollment, subjects will be randomized to receive 3 daily injections of either Albumin or Placebo (liquid with no drug), and will receive 3 brain MRI scans (with and without contrast), as described below.
All subjects will be monitored continuously through 96 hours after enrollment (5 days) in the Georgetown ICU. Blood tests and clinical evaluations of neurological status, consisting of questions about subjects' functional abilities and medical history, will occur in the Georgetown ICU once every 24 hours through post-enrollment Day 5. Additionally, subjects will receive daily chest x-rays, and daily EKGs (exams that monitor how your heart is doing by placing electrodes, or small monitors, on your skin in specific locations).
Similar clinical evaluations will occur at Day 30 and Day 90. Should subjects be discharged at these time points, day 30 assessments will occur over the phone, and day 90 assessments will occur in-person at Georgetown University Medical Center.
We aim to determine the safety and explore the efficacy of human albumin as a neuroprotective (or cytoprotective) agent for the treatment of acute primary supratentorial ICH. Albumin therapy has been shown to be cytoprotective in animal studies of both ischemic stroke and intracerebral hemorrhage, and in a phase II human study in ischemic stroke.
To date no acute intervention (beyond supportive medical care) has been identified to improve outcomes in patients with primary ICH. Neuronal injury from a primary ICH is due not only to the space occupying effects of the hemorrhage but also due to the development of edema and toxicity from blood breakdown products in the subacute phase. Cytoprotective strategies targeted to limit blood brain barrier (BBB) breakdown and edema formation hold promise as treatment strategies to limit this injury.
A number of MR imaging outcome markers demonstrating a potential neuroprotective effect include measures of hematoma volume, perihematomal edema, and blood brain barrier disruption. The term "hyperintense acute injury marker" (HARM) has been proposed to describe the radiologic finding of hyperintense signal within the cerebrospinal fluid spaces visualized on post-contrast fluid attenuated inversion recovery (FLAIR) MRI in patients with acute ischemic stroke. HARM has the potential to serve as a marker of blood brain barrier disruption in patients with primary ICH. The current study will involve serial MR imaging in ICH patients randomized to placebo vs. albumin to assess whether there are differences in the frequency of HARM and perihematomal edema in the albumin treated patients.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Albumin, Placebo, Brain MRI with and without contrast
Georgetown University Hospital
District of Columbia
Published on BioPortfolio: 2014-08-27T03:18:51-0400
Intracerebral hemorrhage is bleeding into the brain and is a major cause of stroke and other complications. Brain injury from intracerebral hemorrhage occurs in two phases. The early phas...
The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the se...
The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage. The purpose of this study is to determi...
The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the progno...
Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed eff...
Intracerebral hemorrhage (ICH) is a lethal cerebrovascular disorder with a high mortality and morbidity. The pathophysiological mechanisms underlying ICH-induced secondary injury remain unclear.
The blood-brain barrier (BBB) disruption and the following development of brain edema, is the most life-threatening secondary injury after intracerebral hemorrhage (ICH). This study is to investigate ...
Hydrogen inhalation has been found to be neuroprotective and anti-oxidative in several brain injury models. Building on these studies, we investigated potential neuroprotective effects of hydrogen inh...
Intracerebral hemorrhage (ICH) is one of the deadliest forms of stroke in the USA. Conventional surgical techniques such as craniotomy or stereotactic aspiration disrupt a large volume of healthy brai...
Accurate and reliable clinical and radiological predictors of intracerebral hemorrhage (ICH) outcomes are needed to optimize treatment of ICH. The aim of this study was to investigate functional outco...
Bleeding within the brain as a result of penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA. Traumatically induced hemorrhages may occur in any area of the brain, including the CEREBRUM; BRAIN STEM (see BRAIN STEM HEMORRHAGE, TRAUMATIC); and CEREBELLUM.
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).
A spectrum of pathological conditions of impaired blood flow in the brain. They can involve vessels (ARTERIES; or VEINS) in the CEREBRUM, the CEREBELLUM, and the BRAIN STEM. Major categories include INTRACRANIAL ARTERIOVENOUS MALFORMATIONS; BRAIN ISCHEMIA; CEREBRAL HEMORRHAGE; and others.
Cell surface proteins that bind albumin with high affinity and trigger intracellular changes influencing the behavior of cells.
Serum albumin from cows, commonly used in in vitro biological studies. (From Stedman, 25th ed)
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...