The researchers at BASIC have conducted numerous other smaller scale studies with the aim of improving the care and outcome of patients with traumatic brain injury, spinal cord injury and other neurosurgical disease processes.
SFGH has been awarded a National Institutes of Health (NIH) Neurological Emergencies Treatment Trials (NETT) network grant for its attempts to improve the immediate care and research of neuroemergencies with treatments delivered within minutes rather than hours after the onset of the issue. NETT initiatives explore the narrow window of opportunity existing in the treatment of neurologic damage from pathologies including stroke, traumatic brain injury, seizures and meningitis. The San Francisco Principal Investigator is J. Claude Hemphill III, MD, MAS. A few of the trials currently under way in San Francisco today are the ALIAS 2, POINT, SHINE, and ProTECT trials\
To learn more about NETT and these trials visit:
Ischemic Stroke Trials
Every year over 750,000 people suffer from strokes in the United States alone. Over 140,000 of these incidents are fatal, making strokes the third largest cause of death in the United States. Ischemic strokes, or the blocking of artery that leads to the brain, make up 88 percent of all strokes. The brain is dependent on arteries to provide it with essential nutrients and oxygen to continue functioning, so when an artery is blocked, extensive tissue damage can occur. BASIC, working in conjunction with NETT, is involved in a number of trials that are attempting to find a way to either ease the effects of ischemic strokes, or to prevent more serious ischemic strokes in patients who have already suffered small scale ones. These trials are ALIAS 2, POINT, and SHINE.
ALIAS 2 (Albumin in Acute Stroke Part 2)
The purpose of the ALIAS trial is to evaluate the effectiveness of high-dose, intravenous human serum albumin in ischemic stroke. Human serum albumin is a naturally produced protein already in clinical use for a variety of medical issues. In animal laboratory studies, it has been shown to reduce the size of the infarction (amount of tissue death) in the brain and improve neurological function after a stroke. Evidence also suggests that albumin decreases or eliminates any brain swelling that may occur after a stroke. These effects may reduce or prevent potential brain damage resulting from a stroke.
For more information visit: http://nett.umich.edu/nett/alias
POINT (PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE TRIAL)
POINT is a randomized, double blind, multicenter clinical trial to determine whether clopidogrel, an antiplatelet drug that attempts to stop harmful blood clots, is effective in improving survival after a mini stroke. The study tracks the long term health of patients who have been administered the study drug to see if clopidogrel can have a positive effect in lowering the number of future major ischemic vascular events such as ischemic stroke, myocardial infarction, and ischemic vascular death. The study drug is initiated within 12 hours of the onset of symptoms of TIA or minor ischemic stroke. Patients receive the study drug along with aspirin 50-325 mg/day.
For more information visit: http://www.pointtrial.org/
SHINE (STROKE HYPERGLYCEMIA INSULIN NETWORK EFFORT)
Of the approximately 750,000 people who suffer from a stroke each year in the United States, roughly 40 percent are hyperglycemic (have very high blood sugar) when they arrive at the hospital. There is a clear association between a poorer clinical outcome and hyperglycemia in stroke patients. SHINE is a multicenter, randomized, controlled clinical trial that evaluates the safety and effectiveness of glucose control using insulin in hyperglycemic patients. SHINE will have a large impact on stroke treatment as healthcare providers currently treat many hyperglycemic stroke patients every day without research and evidence to devise the best plan for therapy. No matter what the ultimate results of this trial, it will no doubt guide the treatment of acute hyperglycemic stroke patients in hospitals everywhere. ]
For more information visit: http://www.shinetrial.org/
ProTECT III is a research study designed to see if progesterone, a hormone naturally produced in the body, can reduce the amount of brain damage caused by a traumatic brain injury. Previous studies suggest that progesterone, given immediately after a TBI, may help treat brain injuries by reducing brain swelling and damage.
There is no specific drug treatment for the treatment of traumatic brain injury. The reason for doing this study is to find out if progesterone is a safe, successful pharmaceutical way to treat TBI, and the brain damage that TBI causes. If the trial is successful, and progesterone does help brain injury patients get better, it will mean a big improvement in TBI treatment!
For more information visit: http://protectiii.com/
For further information on these and all of the NETT trials, please see:
Neurological Emergency Treatment Trials
SFGH is involved in several projects involving imaging as a means of determining severity of injury and long-term outcome.
THE POST-TRAUMATIC SYNDROME OF BLUNT HEAD INJURY: Noninvasive Neurochemical and Structural Assessment
This is a study of the relationship between symptoms experienced after traumatic brain injury and possible areas of damage in the brain after mild and moderate traumatic brain injury. This study is funded by the Department of Defense. The principal investigator is Grant Gauger, MD, PhD.
MAGNETOENCEPHALOGRAPHY AND HIGH-FIELD DIFFUSION TENSOR MAGNETIC RESONANCE IMAGING OF NEURAL FUNCTION AND CONNECTIVITY IN TRAMATIC BRAIN INJURY
This study utilizes MRI to determine if a relationship exists between memory and attention problems and corresponding areas of damage in the brain after traumatic brain injury. This is funded through a grant from UCSF. The principal investigator is Pratik Mukherjee, MD, PhD.
MACROSTRUCTURAL AND MICROSTRUCTURAL IMAGING BIOMARKERS OF TRAMAUTIC BRAIN INJURY
This study seeks to understand if a specific type of brain scan can predict recovery after a tra
umatic brain injury. As part of this study, blood is obtained to determine how genetic differences may affect a patient's recovery. Pratik Mukherjee, MD, PhD is the principal investigator.
SFGH is also interested in how the individual patient responds to treatments and how their genetic make up contributes to their overall outcome.
GENETIC MARKERS TO PREDICT RESPONSE IN TRAUMATIC BRAIN INJURY
The goal of this study is to learn more about the responses to treatment in patients who have suffered serious traumatic brain injury and how genetic differences may affect their recovery. The principal investigator is Geoffrey Manley, MD, PhD.
PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE TRIAL (POINT)
This is a randomized, double blind, multicenter clinical trial to determine whether clopidogrel is effective in improving survival that is free from major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days.
Study drug treatment must be initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day.