2 research outputs found
Dutch Prospective Observational Study on Prehospital Treatment of Severe Traumatic Brain Injury: The BRAIN-PROTECT Study Protocol
Background: Severe traumatic brain injury (TBI) is associated with a high mortality rate and those that survive
commonly have permanent disability. While there is a
broad consensus that appropriate prehospital treatment is
crucial for a favorable neurological outcome, evidence to
support currently applied treatment strategies is scarce. In
particular, the relationship between prehospital treatments
and patient outcomes is unclear. The BRAIN-PROTECT
study therefore aims to identify prehospital treatment
strategies associated with beneficial or detrimental outcomes. Here, we present the study protocol. Study
Protocol: BRAIN-PROTECT is the acronym for BRAin
INjury: Prehospital Registry of Outcome, Treatments and
Epidemiology of Cerebral Trauma. It is a prospective
observational study on the prehospital treatment of
patients with suspected severe TBI in the Netherlands.
Prehospital epidemiology, interventions, medication strategies, and nonmedical factors that may affect outcome are
studied. Multivariable regression based modeling will be
used to identify confounder-adjusted relationships
between these factors and patient outcomes, including
mortality at 30 days (primary outcome) or mortality and
functional neurological outcome at 1 year (secondary outcomes). Patients in whom severe TBI is suspected during
prehospital treatment (Glasgow Coma Scale score 8 in
combination with a trauma mechanism or clinical findings
suggestive of head injury) are identified by all four helicopter emergency medical services (HEMS) in the
Netherlands. Patients are prospectively followed up in 9
participating trauma centers for up to one year. The
manuscript reports in detail the objectives, setting, study
design, patient inclusion, and data collection process.
Ethical and juridical aspects, statistical considerations, as
well as limitations of the study design are discussed.
Discussion: Current prehospital treatment of patients
with suspected severe TBI is based on marginal evidence,
and optimal treatment is basically unknown. The BRAINPROTECT study provides an opportunity to evaluate and
compare different treatment strategies with respect to
patient outcomes. To our knowledge, this study project is
the first large-scale prospective prehospital registry of
patients with severe TBI that also collects long-term follow-up data and ma