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Published on: March 26, 2019
Prognostication in critically ill patients with severe traumatic brain injury: the TBI-Prognosis multicentre
Alexis F Turgeon1,2, François Lauzier1,2, Ryan Zarychanski3
1Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Centre, Québec City, Québec, Canada.
Insights
This feasibility study shows that a large, multicenter prospective study on severe traumatic brain injury (TBI) is achievable. High compliance in data collection and follow-up supports future prognostic modeling for TBI patients.
Area of Science:
- Neuroscience
- Critical Care Medicine
- Clinical Trials
Background:
- Severe traumatic brain injury (TBI) is a major cause of death and disability in young adults.
- Assessing long-term neurological outcomes in TBI patients is challenging due to inherent uncertainties.
- Developing accurate prognostic models is crucial for guiding patient care and resource allocation.
Purpose of the Study:
- To determine the feasibility of a large, multicenter prospective study for severe TBI patients.
- To establish the viability of developing a prognostic model for long-term neurological outcomes.
- To assess key feasibility metrics including patient enrollment, data collection, and follow-up compliance.
Main Methods:
- A prospective cohort study design was employed across 9 Canadian intensive care units.
- Systematic collection of clinical, biological, radiological, and electrophysiological data within the first week post-TBI.
- Assessment of mortality and functional outcomes using the Glasgow Outcome Scale extended at discharge and at 3, 6, and 12 months post-injury.
Main Results:
- Successfully enrolled 50 patients over 12 months, with a 43% enrollment rate.
- High compliance with protocolized test procedures (92%-100%) and excellent follow-up rates (no loss at 6 months).
- Identified key barriers to enrollment, including time window limitations and oversight.
Conclusions:
- The study met its feasibility objectives regarding compliance, enrollment, and follow-up.
- A large-scale, multicenter prospective study (TBI-Prognosis) for severe TBI in Canada is feasible.
- Findings support the initiation of a definitive study to develop a robust prognostic model for TBI outcomes.
Objective:
Severe traumatic brain injury is a significant cause of morbidity and mortality in young adults. Assessing long-term neurological outcome after such injury is difficult and often characterised by uncertainty. The objective of this feasibility study was to establish the feasibility of conducting a large, multicentre prospective study to develop a prognostic model of long-term neurological outcome in critically ill patients with severe traumatic brain injury.
Design:
A prospective cohort study.
Setting:
9 Canadian intensive care units enrolled patients suffering from acute severe traumatic brain injury. Clinical, biological, radiological and electrophysiological data were systematically collected during the first week in the intensive care unit. Mortality and functional outcome (Glasgow Outcome Scale extended) were assessed on hospital discharge, and then 3, 6 and 12 months following injury.
Outcomes:
The compliance to protocolised test procedures was the primary outcome. Secondary outcomes were enrolment rate and compliance to follow-up.
Results:
We successfully enrolled 50 patients over a 12-month period. Most patients were male (80%), with a median age of 45 years (IQR 29.0-60.0), a median Injury Severity Score of 38 (IQR 25-50) and a Glasgow Coma Scale of 6 (IQR 3-7). Mortality was 38% (19/50) and most deaths occurred following a decision to withdraw life-sustaining therapies (18/19). The main reasons for non-enrolment were the time window for inclusion being after regular working hours (35%, n=23) and oversight (24%, n=16). Compliance with protocolised test procedures ranged from 92% to 100% and enrolment rate was 43%. No patients were lost to follow-up at 6 months and 2 were at 12 months.
Conclusions:
In this multicentre prospective feasibility study, we achieved feasibility objectives pertaining to compliance to test, enrolment and follow-up. We conclude that the TBI-Prognosis prospective multicentre study in severe traumatic brain injury patients in Canada is feasible.
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