Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study.
In 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.



We 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.



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 TBIs, with subdural hemorrhages being the most common.



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.
Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI.|Department of Pediatrics, The Ohio State University, Nationwide Children's Hospital, Columbus, OH.
Rachel M
RM
Stanley
Division of Pediatric Emergency Medicine, University of Utah, Salt Lake City, UT.
Michael D
MD
Johnson
Departments of Emergency Medicine and Pediatrics, University of California, Davis School of Medicine, Sacramento, CA.
Cheryl
C
Vance
Department of Pediatrics, Children's Hospital Colorado, Denver, CO.
Lalit
L
Bajaj
Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
Lynn
L
Babcock
Department of Emergency Medicine, Children's National Medical Center, Washington, DC.
Shireen
S
Atabaki
Children's Hospital of Wisconsin, Section of Pediatric Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.
Danny
D
Thomas
Departments of Pediatrics and Emergency Medicine, Emory University, Children's Healthcare of Atlanta, Atlanta, GA.
Harold K
HK
Simon
Department of Pediatrics, The Ohio State University, Nationwide Children's Hospital, Columbus, OH.
Daniel M
DM
Cohen
Department of Pediatric Medicine, Emergency Medicine, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.
Daniel
D
Rubacalva
Division of Neurosurgery, Barrow Neurological Institute at Phoenix Children's Hospital, Phoenix, AZ.
P
P
David Adelson
Division of Emergency Medicine, Phoenix Children's Hospital, Phoenix, AZ.
Blake
B
Bulloch
Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI.
Alexander J
AJ
Rogers
Division of Pediatric Emergency Medicine, Children's Hospital of Michigan, Wayne State University, Detroit, MI.
Prashant
P
Mahajan
Department of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA.
Jill
J
Baren
Division of Emergency Medicine, Boston Children's Hospital, Boston, MA.
Lois
L
Lee
Division of Pediatric Emergency Medicine, Emergency Medicine, Helen DeVos Children's Hospital, Grand Rapids, MI.|Department of Emergency Medicine, Michigan State University, Grand Rapids, MI.|Departments of Emergency Medicine and Pediatrics/Adolescent Medicine, Western Michigan University School of Medicine, Kalamazoo, MI.
John
J
Hoyle
Division of Pediatric Emergency Medicine, Washington University School of Medicine, St. Louis, MO.
Kimberly
K
Quayle
Division of Pediatric Critical Care, PECARN Data Coordinating Center, University of Utah, Salt Lake City, UT.
T
T
Charles Casper
Division of Pediatric Critical Care, PECARN Data Coordinating Center, University of Utah, Salt Lake City, UT.
J
J
Michael Dean
Departments of Emergency Medicine and Pediatrics, University of California, Davis School of Medicine, Sacramento, CA.
Nathan
N
Kuppermann
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital; D005260:Female; D015600:Glasgow Coma Scale; D016489:Head Injuries, Closed / Q000000981:diagnostic imaging* / Q000628:therapy*; D006801:Humans; D007223:Infant; D007258:Informed Consent; D008297:Male; D018579:Patient Selection; D011446:Prospective Studies; D013997:Time Factors; D014057:Tomography, X-Ray Computed