The ADAPT Trial Hits Landmark for Pediatric TBI

The groundbreaking ADAPT Trial completed its first year of enrollment on February 21, 2015. ADAPT (Approaches and Decisions for Acute Pediatric TBI) is an observational cohort study of children with severe traumatic brain injury that is intended to determine best practices in 6 areas of patient care (hyperosmolar therapies, cerebrospinal fluid diversion, hyperventilation, hypoxia detection, nutrition and glucose management) using comparative effectiveness statistical approaches. The study is led by Dr. Micheal Bell, Professor of Critical Care Medicine and Associate Director of the Safar Center at the University of Pittsburgh, and Dr. Stephen Wisniewski, Professor of Epidemiology and Associate Provost of the University of Pittsburgh. Currently, there are 46 sites actively enrolling around the world, with 4 additional sites coming on in the near future. Sites are located in the United States, United Kingdom, Spain, Netherlands, Australia, New Zealand, India and South Africa. A total of 265 children have been enrolled to date – making it one of the largest studies of critically-ill children, and the largest prospectively-enrolling study, for children with severe TBI. More than 250 investigators, research coordinators, data entry assistants, neuropsychologists, co-investigators and statisticians are working on the study with a goal of enrolling 1000 children in the next 2 to 3 years.  A remarkable eleven ancillary studies have been reviewed and are being considered for the study. An Observational Safety Monitoring Board has been empaneled and is meeting in March 2015 to review the existing data.