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Upstate embarks on traumatic brain injury clinical trial

Upstate Medical University has been chosen to join a national $32 million multi-institutional clinical trial to improve patient outcomes following severe traumatic brain injury (TBI). The study is funded by the National Institutes of Health. 

As a Level One Trauma center, Upstate sees more than 100 severe traumatic brain injuries per year. Upstate principal investigator Devin J. Burke, MD, said Upstate’s high trauma volume and experience with the procedures needed for the trial made it a good candidate to join the 50 other sites nationwide in the trial.

“It is a big step for our neuro ICU to be involved in this important multi-institutional trial and it highlights our capabilities,” Burke said. “We look forward to doing more of these trials in the future to better serve our patients who suffer from morbid neurological disease.”

Burke said that 35 percent of patients with severe TBI die after six months and of those that survive, 80 percent will have lifelong disabilities. People most commonly get TBIs from fall, motor vehicle crash, assault or firearm-related injury. Those populations most at risk are adults over 60, children up to age four and young adults, ages 15 to 24.

The study, BOOST-3, is a randomized controlled clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with (TBI) in the intensive care unit. Specifically, the study will determine the safety and efficacy of a strategy guided by treatment goals based on intracranial pressure and brain tissue oxygen as compared to a strategy based on intracranial pressure alone. Both of these strategies are currently used in standard care, but it is unknown whether one is more effective.

Burke, assistant professor of neurology, said that this trial is unique because eligible participants will be patients who come into the Emergency Department unconscious due to their severe TBI and therefore unable to give consent. To remedy this conflict, the Federal Drug Administration established the Exception from Informed Consent (EFIC) policy to allow emergency research in life-threatening circumstances if the patient is incapacitated. (Consent will be obtained from the patient’s legally authorized representative as soon as identified and feasible.)

To participate in an EFIC study, Burke and team have to complete six community consultation sessions within the local demographics that are most susceptible to TBI. To that end, he has been meeting with senior groups, bicycling groups and college students.

“We canvas their thoughts on the trial itself and the ethics of enrollment,” he said.

Burke’s team also has to fulfill six criteria that involve public disclosure which include flyers, newspaper ads, press releases and social media posts. Once both of these criteria are met in the coming months, an external review board will approve Upstate to move forward to the clinical trial and Burke expects the trial to start in the next few months.

The trial is a multidisciplinary endeavor between the departments of Neurology, Neurosurgery, Surgery, and Emergency Medicine. Co-investigators include Timothy Beutler, MD, neurosurgery; Roseanna Guzman-Curtis, MD, surgery; and Sarah Mahonski, MD, emergency medicine. Burke is assisted by Lena Deb, a clinical research associate.

Caption: Leading the clinical trial are, from left, Tim Beutler, MD, Neurosurgery; Devin Burke, MD, Neurocritical Care; and Roseanna Guzman-Curtis, MD, MPH, trauma medical director. Burke is the study's principal investigator; Beutler and Guzman-Curtis are co-investigators.