SANTA CLARA COUNTY, CALIF.—Approximately 1.5 million people suffer from Traumatic Brain Injuries (TBIs) each year, and TBIs are the leading cause of disability for individuals under age 44. Santa Clara Valley Medical Center is joining Stanford University Medical Center in the Progesterone for the Treatment for Traumatic Brain Injury (ProTECT) collaborative study to research if the administration of progesterone improves patient recovery.
"We can achieve exponentially more when public and private entities work together," said Board of Supervisors President Ken Yeager. "As one of three trauma centers in Santa Clara County, VMC is an ideal partner for Stanford in this important study."
A Traumatic Brain Injury is an injury to the brain caused by an outside force such as during a fall or a car accident. A TBI can be a life-threatening medical emergency, and accounts for 40 percent of all deaths from acute injuries in the U.S. It is the cause of death in 50 percent of all motor vehicle accidents. Each year, one out of 1,000 Americans sustains a TBI. The annual cost of TBI in the United States exceeds $80 billion per year.
Through this clinical study, researchers want to determine if giving the hormone progesterone with standard medical care will work better than standard medical care alone in reducing the brain damage caused by a Traumatic Brain Injury. Progesterone is a normally occurring hormone in human bodies and is used to treat other conditions, but it is not currently used or approved by the Federal Drug Administration to treat TBIs. Previous studies suggest progesterone, when given immediately, may reduce brain swelling and damage.
"There have been no new drug treatments for Traumatic Brain Injuries in nearly 30 years," said Roland Torres MD, a Stanford neurosurgeon and Acting Chief of Neurosurgery at Valley Medical Center. Dr. Torres is a nationally recognized Neurotrauma and Neuro-Critical Care expert and co-investigator on this study and the STANFORD NETT. "Our primary objective is to determine whether or not progesterone will improve the patient's recovery."
TBIs must be treated quickly, and progesterone as part of the clinical trial, must be given within four hours of the injury. The difficulty is that most TBI patients are not alert enough and unable to give consent or have it attained from their legally authorized representatives before treatment needs to start. The National Institute of Health is sponsoring a large clinical trial under the FDA Final Rule 21 CFR 50.24 which allows for an exception from informed consent.
When an adult with a new Traumatic Brain Injury is brought to the emergency department, all standard medical care will be given. In addition, the doctor will screen the patient to see if he is eligible for the research study. If the patient arrives at the emergency department less than 4 hours after their injury, the individual could be included. If a patient's legally authorized representative cannot be located within one hour of the patient's arrival at the hospital, the patient will be started on the study medicine without consent. Once the representative is located, he will be asked to give permission for the patient to continue in the study. If he does not give permission, the study medicine will be stopped. The trials will enable the researchers to see whether or not progesterone works to decrease brain damage from a Traumatic Brain Injury.
"The County's participation in this kind of nationwide study reflects a critical aspect of services we provide at VMC, keeping us at the forefront of improved techniques and setting the standard of care," said County Executive Jeff Smith.
The national trial will involve a maximum of 1,140 random individuals from more than 30 hospital complexes. The clinical trial duration period per person is six months. The study is part of the Neurological Emergencies Treatment Trials (NETT) which have 17 institutions nationwide with collaborations from emergency physicians, neurologists and neurosurgeons. VMC participates in the NETT through a relationship with Stanford University. For more information about the study, go to http://med.stanford.edu/.
Media Contact: Gwendolyn Mitchell/Laurel Anderson, Office of Public Affairs (408) 299-5119; Joy Alexiou, Santa Clara Valley Health & Hospital System, (408) 885-4164
Posted: January 15, 2010