Faculty Collaboration Database

Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study. Acad Emerg Med 2017 Jan;24(1):31-39

Date

09/13/2016

Pubmed ID

27618167

DOI

10.1111/acem.13085

Scopus ID

2-s2.0-85009211843 (requires institutional sign-in at Scopus site)   11 Citations

Abstract

OBJECTIVES: 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.

METHODS: 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.

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 TBIs, 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.

Author List

Stanley RM, Johnson MD, Vance C, Bajaj L, Babcock L, Atabaki S, Thomas D, Simon HK, Cohen DM, Rubacalva D, David Adelson P, Bulloch B, Rogers AJ, Mahajan P, Baren J, Lee L, Hoyle J, Quayle K, Charles Casper T, Michael Dean J, Kuppermann N, Pediatric Emergency Care Applied Research Network (PECARN)

Author

Danny G. Thomas MD, MPH Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Child
Child, Preschool
Emergency Service, Hospital
Female
Glasgow Coma Scale
Head Injuries, Closed
Humans
Infant
Informed Consent
Male
Patient Selection
Prospective Studies
Time Factors
Tomography, X-Ray Computed