$32M BOOST-3 trial aims to improve severe TBI outcomes

Many patients who suffer severe traumatic brain injuries (TBI) are left permanently disabled and the condition has been linked to an increased risk of suicide.

A new clinical trial—Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST-3)—will build off prior research with a goal of improving outcomes of those victims of severe TBI, according to a University of Michigan release.

“Of the nearly 300,000 hospital admissions annually for TBI, about 40 percent are classified as severe,” said William Barsan, MD, a principal investigator of the trial, in the release. “Unfortunately, less than 20 percent of patients with a severe TBI make a good recovery—and many are left with lifelong disabilities and medical needs.”

The $32 million BOOST-3 trial will kick-off this year, enrolling 1,094 participants with severe TBI across 45 National Institutes of Health-funded Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) sites.

All subjects will be randomized within six hours upon arriving at a participating hospital and no more than 12 hours from injury-diagnosis. They will be followed for six months to measure functional outcomes and neurological function. The entire trial will last five years, the release noted.

Traditionally, intensive care unit providers monitor intracranial pressure to manage severe TBI patients and treat elevated pressure to avoid additional injury, Barsan said.

The BOOST-2 trial, published in 2017, found that low levels of brain tissue oxygen can prevent further recovery in severe TBI patients, suggesting understanding pressure and oxygen in the brain may be key to a more timely intervention.

Researchers leading the third phase of this trial will operate under a new hypothesis: “Treating TBI based on partial pressure of oxygen in the brain tissue and intracranial pressure monitoring will improve neurological outcomes six months after the injury compared with treatment based on intracranial pressure monitoring alone,” the release read.

Investigators of the new trial hope their upcoming research will change the way those with severe TBI recover.

“We truly hope this clinical trial will provide emergency, neurosurgery and critical care physicians with improved treatment protocols for severe TBI going forward,” Barsan said. “Our main goal is to improve long-term outcome and improve quality of life after severe TBI through the results of the BOOST-3 trial.”