• Rachel M Stanley, Michael D Johnson, Cheryl Vance, Lalit Bajaj, Lynn Babcock, Shireen Atabaki, Danny Thomas, Harold K Simon, Daniel M Cohen, Daniel Rubacalva, David Adelson P P Division of Neurosurgery, Barrow Neurological Institute at Phoenix Children's Hospital, Phoenix, AZ., Blake Bulloch, Alexander J Rogers, Prashant Mahajan, Jill Baren, Lois Lee, John Hoyle, Kimberly Quayle, Charles Casper T T Division of Pediatric Critical Care, PECARN Data Coordinating Center, University of Utah, Salt Lake City, UT., Michael Dean J J Division of Pediatric Critical Care, PECARN Data Coordinating Center, University of Utah, Salt Lake City, UT., Nathan Kuppermann, and Pediatric Emergency Care Applied Research Network (PECARN).
• Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI.
• Acad Emerg Med. 2017 Jan 1; 24 (1): 31-39.

ObjectivesIn preparation for a clinical trial of therapeutic agents for children with moderate-to-severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to (1) determine the number and clinical characteristics of eligible children, (2) determine the timing of patient and guardian arrival to the ED, and (3) describe the heterogeneity of TBIs on computed tomography (CT) scans.MethodsWe conducted a prospective observational study at 16 EDs of children ≤ 18 years of age presenting with blunt head trauma and Glasgow Coma Scale scores of 3-12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings.ResultsWe enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and nonsurvivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2 hours of injury, but most guardians did not arrive until 2-3 hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common.ConclusionEnrolling children with moderate-to-severe TBI into time-sensitive clinical trials will require large numbers of sites and meticulous preparation and coordination and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children.© 2016 by the Society for Academic Emergency Medicine.

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