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Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study
Rachel M Stanley1,2, Michael D Johnson3, Cheryl Vance4
1Department of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI.
Insights
Conducting clinical trials for pediatric traumatic brain injuries (TBIs) is feasible but challenging. Delays in guardian arrival complicate informed consent, necessitating careful planning and consideration of federal exceptions for emergency research.
Area of Science:
- Pediatric emergency medicine
- Neurotrauma research
- Clinical trial feasibility
Background:
- Moderate-to-severe traumatic brain injuries (TBIs) in children require effective therapeutic agents.
- Emergency departments (EDs) are critical points for identifying eligible pediatric TBI patients.
- Feasibility studies are essential for planning complex clinical trials.
Purpose of the Study:
- Assess the eligibility and characteristics of pediatric patients with moderate-to-severe TBIs in EDs.
- Determine the arrival times of pediatric TBI patients and their guardians to the ED.
- Describe the diversity of TBI presentations on computed tomography (CT) scans.
Main Methods:
- Prospective observational study conducted at 16 EDs.
- Inclusion criteria: children (≤18 years) with blunt head trauma and Glasgow Coma Scale scores of 3-12.
- Data collected on patient eligibility, arrival times, demographics, injury severity, and CT findings.
Main Results:
- 295 eligible children enrolled over 6 months.
- Exclusion criteria for future trials included cardiac arrest and nonsurvivable injuries.
- Most children arrived within 2 hours, but guardians often arrived 2-3 hours post-injury.
- Subdural hemorrhages were the most common TBI type observed.
Conclusions:
- Enrolling children with moderate-to-severe TBI in time-sensitive trials demands extensive site coordination.
- Guardian arrival delays pose significant challenges for obtaining informed consent.
- The Federal Exception from Informed Consent for Emergency Research is crucial for enrolling pediatric TBI patients.
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.
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