The Elvis Presley Memorial Level 1 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 NIH.
The Elvis Presley Memorial Level 1 Trauma Center at the Regional Medical Center at Memphis (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). Led locally by University of Tennessee Health Science Center investigators Timothy C. Fabian, MD, and Martin A. Croce, MD, the study will evaluate the use of hypertonic saline (concentrated salt) solutions given intravenously to patients with traumatic brain injuries. A recently completed phone survey of citizens randomly selected from Memphis and the surrounding area revealed solid community support for the study. Enrollment is expected to begin within the next few weeks.
Under the study protocol, treatment will be given prior to arrival at the hospital, either at the scene of the injury or in the air ambulance. The purpose of the study is to determine if administering hypertonic saline solutions to patients with traumatic brain injuries will improve their outcomes.
Swelling of the brain is a common occurrence after trauma to the head. Because there is limited space for swollen tissue in the head to expand, circulation of blood to the brain is often compromised as pressure in the head rises and blood vessels are compressed. Paramedics routinely establish intravenous access at the scene of the injury so that fluids can be injected directly into a vein as needed. This process is known as “resuscitation.” The standard fluid (normal saline solution) used in this process is isotonic fluid or fluid that has a similar salt concentration as blood. Because it has a higher salt concentration than standard treatments, a hypertonic solution should hold fluid inside the blood vessels and prevent its escape to the injured tissue. This should result in less swelling of the brain, which should, in turn, decrease pressure inside the head. The study is expected to demonstrate that infusing a hypertonic fluid can help restore blood flow to the brain by decreasing the amount of swelling that occurs in injured brain tissue.
Two different types of hypertonic fluids will be administered in this study. One is a hypertonic saline solution without additives, while the second is a hypertonic saline solution with the addition of dextran. Dextran is a sugar solution that is expected to augment the effects of hypertonic saline and prolong the benefits for an additional period of time. Although hypertonic saline solutions have been tested in eight pervious trials with no related adverse side effects reported, potential problems include temporary high blood pressure, rash and other allergic reactions, a temporary change in the body’s ability to clot blood, a temporary change in blood chemistry (such as elevated sodium and blood sugar levels), and there may be effects that are unknown presently.
In the upcoming trial, male and female patients over 18 years of age who are severely injured, bleeding, and in shock will be eligible to be enrolled in the study. Women who are believed to be pregnant will not be eligible for participation. Prior to hospital arrival, enrolled patients will be randomly assigned to receive either the standard-of-care or one of the hypertonic saline solutions followed by standard-of-care solutions as needed.
“We are very excited to be included in this important clinical trial,” commented study investigators Drs. Fabian and Croce. In North America, traumatic brain injury is the most common cause of death and disability in young adults. Each year, more than 1.6 million people sustain this type of injury. “If we begin to treat patients with severe brain injuries more effectively very early after injury, we could see better outcomes,” Dr. Fabian added.
Because eligible patients for this study are unlikely to be able to provide informed consent due to the extent and nature of their injuries, the study will be conducted under federal regulations that allow clinical research in emergency settings using an exception from the requirement for informed consent (21 CFR 50.24). Use of this provision in a study protocol is granted when the University of Tennessee Health Science Center Institutional Review Board, the board that approves research studies conducted at The MED and oversees initial and continuing review, finds that: patients are in a life-threatening situation requiring emergency medical intervention; currently available treatments are unsatisfactory; potential risks are identified; participation in the study could provide increased chances for survival; and the research could not be practicably conducted without an exception from required informed consent.
Individuals who do not wish to be included in this study in the event of life threatening injury can 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 by contacting the Department of Surgery at the University of Tennessee Health Science Center at (901) 448-4488 or by e-mailing email@example.com.