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Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study
Author(s) -
Stanley Rachel M.,
Johnson Michael D.,
Vance Cheryl,
Bajaj Lalit,
Babcock Lynn,
Atabaki Shireen,
Thomas Danny,
Simon Harold K.,
Cohen Daniel M.,
Rubacalva Daniel,
David Adelson P.,
Bulloch Blake,
Rogers Alexander J.,
Mahajan Prashant,
Baren Jill,
Lee Lois,
Hoyle John,
Quayle Kimberly,
Charles Casper T.,
Michael Dean J.,
Kuppermann Nathan
Publication year - 2017
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/acem.13085
Subject(s) - medicine , glasgow coma scale , observational study , traumatic brain injury , emergency department , clinical trial , informed consent , pediatrics , head injury , emergency medicine , blunt , blunt trauma , pediatric trauma , injury prevention , poison control , surgery , psychiatry , alternative medicine , pathology
Objectives In preparation for a clinical trial of therapeutic agents for children with moderate‐to‐severe blunt traumatic brain injuries ( TBI s) in emergency departments ( ED s), 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 TBI s on computed tomography ( CT ) scans. Methods We conducted a prospective observational study at 16 ED s 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. Results We 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 TBI s, with subdural hemorrhages being the most common. Conclusion Enrolling 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.