Northwell Health will focus on 2 different clinical strategies for monitoring and treating severe traumatic brain injuries.
David Ledoux, MD
The relationship between reduced brain tissue oxygenation and poor outcomes after severe traumatic brain injuries (TBI) is well known, but monitoring and treatment strategies are still lagging behind.
On the heels of a successful phase II clinical trial, neuroscientists from Northwell Health’s Institute for Neurology and Neurosurgery and the Feinstein Institutes for Medical Research will examine a pair of strategies for monitoring and treating patients with severe traumatic brain injuries in a phase III trial at the North Shore University Hospital (NSUH), a level I trauma center.
The first treatment strategy entails doctors preventing high intracranial pressure caused by a swollen brain, while doctors in the second part will look at preventing intracranial pressure and low brain oxygen levels.
“Both of these treatment strategies are used in standard care,” Jamie Ullman, MD, director of neurotrauma at Northwell, said in a statement. “However, it is not known if 1 treatment is more effective than the other.”
The new study, dubbed the Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3) study, will include patients at least 14 years old with severe TBI that requires admission to the intensive care unit (ICU) with brain monitoring.
“Both strategies help doctors adjust treatments, including the kinds and doses of medications, the amount of intravenous fluids administered, ventilator settings, the need for blood transfusions and other medical care,” David Ledoux, MD, Northwell’s chief, neurocritical care, said in a statement. “The results of the BOOST-3 study will help us better understand if one of the treatment methods improves survival and reduces disability.”
In the phase II study, investigators led by David Okonkwo, MD, PhD, University of Pittsburgh School of Medicine, conducted a randomized, prospective clinical trial assessing whether a neurocritcal care management protocol improves brain tissue oxygenation levels for 119 patients with severe traumatic brain injuries at 10 intensive care units in the US.
In the study, patients were randomized to treatment protocol based on intracranial pressure with brain tissue oxygenation monitoring or intracranial pressure monitoring alone.
Tiered interventions in each arm were specified, while the impact on intracranial pressure and brain tissue oxygenation was measured. The monitors were removed if values were normal for 48 consecutive hours or after 5 days and outcomes were measured at 6 months using the Glasgow Outcome Scale-Extended.
The investigators developed a management protocol based on brain tissue oxygenation and intracranial pressure monitoring that reduced the proportion of time with brain tissue hypoxia after severe traumatic brain injury (.45 in intracranial pressure—only group and .16 in intracranial pressure plus brain tissue oxygenation group; P <.0001).
There were not any procedure-related complications found in the study and treatment of secondary injuries after severe traumatic brain injuries based on brain tissue oxygenation and intracranial pressure values were consistent with reduced mortality and increased proportions of patients with good recovery compared with intracranial pressure-only management.
However, the current study was not powered for clinical efficacy.
The study, “Share Favorites Permissions More NEUROLOGIC CRITICAL CARE Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial,” was published online in Critical Care Medicine.