Neuroscientists from Northwell Health Institute and the Feinstein Institutes for Medical Research are examining a couple of strategies for monitoring and treating patients with severe traumatic brain injuries in a Phase III clinical trial at North Shore University Hospital (NSUH), a level I trauma center. This imminent study follows a successful Phase II study.

The Study

Called the Brain Oxygen Optimization in Severe Traumatic Brain Injury (Boost-3), the study will involve patients with severe TBI that involves intensive care unit (ICU) admission with ongoing brain monitoring. MDMag’s Kenny Walter reports that the first treatment strategy involves the effort to prevent high intracranial pressure triggered by a swollen brain; the second prong of the study involves the investigators’ effort to prevent intracranial pressure and low brain oxygen levels. As it turns out, both of these approaches are currently used in the standard of care but what is not known, according to Dr. Jamie Ullman, director of neurotrauma at Northwell, is “if one treatment is more effective than the other.”

David Ledoux, MD, and Northwell’s chief of neurocritical care, commented in a statement that “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.” Dr. Ledoux continued, “The results of the BOOST-3 study will help us better understand if one of the treatment methods improves the survival and reduces disability.

The Previous Phase II Study

Led by David Okonkwo, MD, PhD, University of Pittsburgh School of Medicine, the Phase II study, conducted at 10 intensive care units across America, involved a randomized, prospective clinical trial testing whether a neurocritical care management protocol improves brain tissue oxygenation levels involving 119 patients experiencing severe traumatic brain injuries, reports Walter from MDMag. Dr. Okonkwo is involved with BOOST-3 as well.

About Northwell Health

Northwell Health, a nonprofit integrated healthcare network, is New York State’s largest healthcare provider and private employer with more than 68,000 employees in 2019. By 2019, the integrated health system was home to 23 hospitals and more than 700 outpatient facilities, as well as the Donald and Barbara Zucker School of Medicine at Hofstra/NorthwellThe Feinstein Institute for Medical Research, urgent care centers, kidney dialysis centers, acute inpatient rehabilitation, sub-acute rehabilitation and skilled-nursing facilities, a home care network, a hospice network, and other services. It was formerly known as North Shore-Long Island Jewish Health System and renamed back in 2015. Its flagship hospitals include North Shore University Hospital and Long Island Jewish Medical Center. 

Clinical Trials

Northwell is a major health provider also serving as a clinical research hub—conducting many clinical trials. Its Office of Clinical Research is a key hub for studies across this sprawling health system. Patients can search for clinical trials via their website. Simply find “Therapeutic Specialty” and then select. The website will then offer a number of trials to explore. Once one of the trials is selected, Northwell describes the trial and even provides the name of the principal investigator and contact information.

Lead Research/Investigators

David Ledoux, MD 

Dr. Jamie Ullman, MD 

David Okonkwo, MD 

Source: Critical Care Medicine

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