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Each year, more than 1.6 million people sustain a traumatic brain injury. In North America, traumatic brain injury, such as that sustained in a car accident, is the most common cause of death and disability in young adults. At the Regional Medical Center at Memphis, a Level 1 trauma center, they see 4,000 to 4,500 trauma cases per year, about 500 of which are traumatic brain injuries. Based on their volume and the established clinical research, the Elvis Presley Memorial Trauma Center at the MED is one of a select number of Level 1 trauma centers in the United States chosen to participate in a groundbreaking national clinical trial sponsored by the National Institutes of Health (NIH). The study's directive, led by University of Tennessee Health Science Center (UTHSC) investigators, will determine if administering hypertonic saline solutions to patients with traumatic brain injuries will improve their outcomes. The trial began in December. "Patients with severe brain injuries don't have great treatments and the outcomes are often poor," explained Timothy C. Fabian, MD, chairman of UTHSC department of surgery. "People have been looking for a long time for therapies to improve the situation and one of them appears to be the use of hypertonic solutions." Normal saline has a similar salt concentration to that of human blood. Paramedics routinely establish intravenous access at the scene in order to inject fluids directly into a vein as needed – the process known as resuscitation. Hypertonic saline solution has a sodium concentration eight times than that of standard saline. Because of the higher salt concentration, hypertonic solution can draw more fluid out of the injured tissue and let it escape into the blood vessels, which should result in less swelling in the brain. "If you have edema in the brain, then these hypertonic solutions will, hopefully, mobilize some of that fluid and reduce the intracranial blood pressure," said Fabian. "The idea is if you can reduce the fluid and the pressure, then you'll improve the blood flow to the brain." For at least 15 years, the use of hypertonic solution as a therapy for brain trauma has been studied in small trials. The MED has used hypertonic solutions on brain trauma patients for about 10 years as a standard of care when patients get to a certain level of intracranial pressure. It has definitely decreased that pressure, said Fabian, but the difference with this national study is the hypertonic solution will be administered immediately, at the scene of the accident. This is the first FDA approved national study for hypertonic solutions in traumatic brain injury patients. During this national, federally mandated, multi-site trial, which is part of a national consortium through the Resuscitation Outcomes Coalition (ROC), 12 sites across North America, including Canada, will participate. The goal is to attain 2,100 patients nationally, with about 100 to 200 locally. It will last a year and a half. During the trial, male and female patients who are severely injured, bleeding and in shock will be eligible to enroll in the study. Because these patients will be unable to provide consent due to the nature of their injuries, the study will be conducted under federal regulations for the exception of informed consent, regulations allowed for clinical research such as this used in emergency settings. The study and criteria have been vetted according to federal guidelines and was reviewed by the NIH, various national boards at the UTHSC research advisory board. "It's important for people to know we're not flying by the seat of our pants," maintained Martin Croce, MD, chief of trauma at the MED. "Strict federal rules have to be followed for waiver of consent." Inclusion criteria states that patients must have a Glasgow Outcome Score (GOS), a standard measure of brain injury, of eight or less and it has to be a blunt traumatic injury, such as in a car accident, a fall or assault. Patients must be at least age 15 or more than 110 pounds. Exclusions are prisoners, known or suspected pregnancies, and penetrating brain injuries. The MED study is going to be conducted by paramedics with the helicopter team. Prior to hospital arrival, enrolled patients will be randomly assigned to receive either the standard-of-care or the hypertonic saline solutions followed by standard-of-care solutions as needed. During the study, two different solutions will be used in comparison with normal saline: a hypertonic saline solution without an additive, and a hypertonic saline solution with the addition of Dextran, a sugar solution that will be used to augment the effects of hypertonic saline. Dextran prolongs the effects of hypertonic solution up to four hours. "Ideally, if in fact this works, we hope for a better outcome from brain injury patients," said Croce. "This study alone, it's unrealistic to think it will improve outcomes for all brain injury patients, but we (expect) to identify subgroups of patients." Croce said after this study the next step would be further studies with subgroups and tweaked dosages. "This is not a panacea," added Fabian. "It's not going to solve every brain injury problem but hopefully it will help some patients." NOTE: An exclusion clause is available for persons who do not wish to be included in this study. They can call UTHSC to obtain a bracelet, which when worn, will serve as a signal to paramedics that the wearer does not wish to participate in the study protocol. Bracelets can be obtained through UTHSC at 901-448-4488 or by emailing: trauma@utmem.edu.

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Elvis Presley Memorial Trauma Center, Glasgow Outcome Score, Martin Croce, National Institutes of Health, Regional Medical Center at Memphis, Resuscitation Outcomes Coalition, Timothy C. Fabian, trauma, University of Tennessee Health Science Center

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