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.
SF-NETT Projects
Dr. Claude Hemphill and his colleagues at San Francisco General Hospital and UCSF are one of 17 academic centers selected as a “hub” for the NETT. Each hub acts as a local coordinating center for other participating hospitals, known as “spokes.” The hub of SF-NETT is in the Brain and Spinal Injury Center (BASIC) at San Francisco General Hospital. Spoke hospitals include all San Francisco ambulance destination hospitals (UCSF Medical Center, CPMC, Davies, Kaiser SF, St. Francis, St. Luke’s, and St. Mary’s) as well as Highland Hospital in Oakland.
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 neuro emergencies with treatments delivered within minutes rather than hours after the onset of the issue. The goal of the NETT program and SF-NETT is to create and maintain a clinical research infrastructure to perform streamlined Phase III clinical trials of new treatments for neurological emergencies including status epilepticus, traumatic brain and spinal cord injury, and stroke. 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 underway in San Francisco today are the POINT, SHINE, and ESETT trials
To learn more about NETT and these trials visit: http://www.nett.umich.edu/nett/welcome
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 an 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.
POINT (PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE TRIAL) – Lead Coordinator: Dominica Randazzo
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke.
A TIA is a condition that produces stroke-like symptoms like sudden weakness on one side of the body or trouble speaking, but the symptoms are temporary. A minor ischemic stroke occurs when blood flow is interrupted to part of the brain. Depending on the region of the brain affected, a stroke may cause paralysis, speech impairment, loss of memory and reasoning ability, coma, or death. A stroke is also sometimes called a brain attack or a cerebrovascular accident (CVA).
The best treatment for prevention of another stroke or TIA in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose, including aspirin and clopidogrel. These medications are usually taken for the rest of a patient’s life.
In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes. The study will enroll 5841 patients over a 5-year period. Each participant will be involved in the study for 90 days. One hundred and fifty different institutions are part of this study. About half of the sites will report to the Clinical Coordinating Center, which is located at the University of Michigan, and the remainder will be overseen by the POINT CRC in Rockville, MD.
For more information visit: http://www.pointtrial.org/
Local POINT Contact Information
San Francisco General Hospital Medical Center
Principal Investigator – Claude Hemphill, MD, MAS
Study Nurse – Michele Meeker, RN, BSN
Phone: (415) 206-3220/ E-mail: [email protected]
Primary Coordinator – Dominica Randazzo
Phone: (415) 206-8094/ E-mail: [email protected]
SHINE (STROKE HYPERGLYCEMIA INSULIN NETWORK EFFORT) – Lead Coordinator: Ryan McCormick
Over 750,000 people have strokes in the US annually. Approximately 40% percent of the patients with acute ischemic stroke are hyperglycemic at presentation. Though hyperglycemia is known to be associated with worse clinical outcome, it is unclear if treatment interventions to assure euglycemia can improve outcome and if they do if they can overcome the additional risk of causing hypoglycemia in ischemic brain. We hypothesize that an insulin protocol that maintains euglycemia for 3 days in hyperglycemic acute ischemic stroke patients will improve clinical outcome and be safe.
The Stroke, Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include 56 sites. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites (~45 sites) in addition to ~10 non-NETT sites from all over the United States. The study will evaluate the safety and efficacy of targeted glucose control (treatment group – IV insulin with target 80-130 mg/dl) versus control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL.
The intervention group will utilize and FDA cleared decision support tool to guide the treating team in insulin drip adjustments. The study design includes pre-specified adaptive design methods and a sliding dichotomy primary outcome to maximize the efficiency and power of the trial. The primary outcome will be the functional outcome at 3 months as measured by the modified Rankin Scale (mRS) Score. The primary safety outcome will be severe hypoglycemia defined as <40 mg/dL. Enrollment will occur over 3.5 - 4 years.
The results of this study will have an enormous impact on the stroke community as health care providers currently manage hyperglycemic acute stroke patients every day without adequate evidence of best therapy. Regardless of the results of this trial, it will guide acute stroke management across the country and possibly the world. The purpose of this web page is to notify our community about this trial, to provide contact information and resources where you can learn more, including an option to decline participation.
For more information visit: http://www.shinetrial.org/
Local SHINE Contact Information
San Francisco General Hospital Medical Center
Principal Investigator – Claude Hemphill, MD, MAS
Study Nurse – Michele Meeker, RN, BSN
Phone: (415) 206-3220/ E-mail: [email protected]
Primary Coordinator – Ryan McCormick, MD
Phone: (415) 206-3761/ E-mail: [email protected]
ESETT - The Established Status Epilepticus Treatment Trial – Lead Coordinator: Jeany Duncan
The Established Status Epilepticus Treatment Trial (ESETT) is a multicenter, randomized, double-blind, comparative effectiveness study of fos-phenytoin, levetiracetam, and valproic acid in subjects with benzodiazepine-refractory status epilepticus. Patients will be recruited by two national emergency research networks: Neurology Emergency Treatment Trials (NETT) network and Pediatric Emergency Care and Applied Research Network (PECARN). Each network has successfully undertaken a Status Epilepticus treatment trial under the exception from informed consent (EFIC) rules. At SFGH and UCSF both pediatric and adult patients will be enrolled
This study will enroll a national maximum total sample size of 795 patients over 4 years, at an accrual rate of approximately 16.5 patients per month.
For more detailed information on ESETT visit: http://www.esett.org/
Local ESETT Contact Information
San Francisco General Hospital Medical Center
Principal Invesitigator – Claude Hemphill, MD, MAS
Study Nurse – Michele Meeker, RN, BSN
Phone: (415) 206-3220/ E-mail: [email protected]
Primary Coordinator – Jeany Duncan
Phone: (415) 206-4106/ E-mail: [email protected]
CEREBROTECH-Device Trial – Lead Coordinator: Dominica Randazzo
This is a prospective observational exploratory study with the purpose of validating a novel intracranial fluid monitor, the Cerebrotech Intracranial Fluid (ICF) monitor, against current measures of clinically significant cerebral edema which are used in the regular practice of neurocritical care. These include intracranial pressure (ICP) or tissue shift on CT/MRI. The study will take place at SFGH and UCSF in the ICU and ward setting and will include patients who have been diagnosed with stroke, and require CT imaging as part of their care. This study consist of two main parts 1) feasibility and safety 2) positive linear correlation with imaging and possibly, neuromonitoring results. We expect to enroll up to 20 patients over one to two years to achieve our goal.
Neuro-Imaging Projects
SFGH is involved in several projects involving imaging as a means of determining severity of injury and long-term outcome.
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.
Neurosurgery Projects
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.
