Researchers at Indiana University School of Medicine in collaboration with Goodman Campbell Brain and Spine and Ascension St. Vincent Hospital are learning more about the best way to treat patients suffering from severe head trauma. The new clinical trial, Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3), is aimed at determining the effectiveness of a new strategy for treating patients with traumatic brain injury (TBI) by measuring brain tissue oxygen levels.
“We are looking at utilizing the oxygen tension in brain tissue to help guide the management of severe brain injury,” said Richard Rodgers, MD, the study’s principal investigator. Rodgers is a neurosurgeon at Goodman Campbell Brain and Spine and an adjunct professor of neurosurgery at IU School of Medicine Department of Neurological Surgery. “We now have the ability to monitor oxygen tension in brain tissue with this separate monitor that is approved by the Food and Drug Administration. People have been using these monitors on their own for 10 to 15 years at this point, but there's never been a big study to look at its overall efficacy.”
BOOST-3 is the third phase of BOOST clinical trials. The first two phases of trials looked at the safety and feasibility of measuring brain tissue oxygen levels while also considering intracranial pressure when monitoring and treating patients with TBI. Now, phase three hopes to find out how beneficial the method is through a randomized clinical trial. Some patients will have their oxygen levels monitored along with intracranial pressure, while others will only have their intracranial pressure monitored.
“The goal of BOOST-3 is to find out if there's an outcome difference,” Rodgers said. “If we utilize a specific protocol to manage a brain injury patient using brain tissue and oxygen numbers versus not using those numbers, is there a difference in outcome?”
“For years we've done a lot with patients to improve blood flow and oxygenation to the brain, but we've never been able to measure its effect on the cells of the brain in real time,” said Jeffrey Kline, MD, vice chair of research for IU School of Medicine Department of Emergency Medicine. “If the device helps guide resuscitation, it will then help improve outcome. Then it will shift the way we care and the way we think about treating patients with brain injury. Or, it will refute it and help us know there's something else besides oxygenation that matters.”
The BOOST trials are supported through IU School of Medicine’s participation in the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN), a network made up of several other centers across the country and funded by the National Institutes of Health.
According to SIREN, about 3.5 million Americans sustain a TBI each year. Of those, 50,000 people die. Another 30,000 are hospitalized, but survive. Rodgers said health care workers don’t currently have a medication or other intervention they know will drastically improve a patient’s outcome, but this study could change that.
“We know that keeping a patient in an intensive care unit that knows how to manage brain injuries is better for outcomes, but we don't have a specific intervention that we can say, ‘this makes our care of these patients better,’” Rodgers said. “This ability to monitor brain tissue oxygen would be a marker for knowing if we are supplying a brain with enough nutrients and blood to help it heal from an injury.”
“This is the study that will determine whether or not brain oxygen measurements improve outcome,” Kline said.
The study is expected to last for several years. Patients participating in the trial in Indianapolis will be enrolled at Ascension St. Vincent Hospital. Because these patients are experiencing life-threatening injuries and are often unconscious, they will be enrolled through their legally authorized representative. If a legally authorized representative is not available, they will be enrolled under the exception from informed consent rule.
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.