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.
- Traumatic brain injury
- Pilot study
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Contributors AFT, FL, RZ, DAF, LAM, FB, AR, KB, DG, RG, DCS, MOM, MS, JP, J-LG, AL, KR, GP, DZ and LM were involved in conception and design. AFT, FL, RZ, DAF, CL, LAM, FB, AR, KB, DG, RG, DCS, MOM, MS, MSh, JP, J-LG, AL, KR, DJ, GP, DZ and LM were involved in the acquisition and interpretation of data. AFT, CL and MSh drafted the manuscript. AFT, FL, RZ, DAF, CL, LAM, FB, AR, KB, DG, RG, DCS, MOM, MS, MSh, JP, J-LG, AL, KR, DJ, GP, DZ and LM were involved in revising the manuscript and approved the version published.
Funding This study was funded by the Fonds de la Recherche du Québec—Santé (FRQS) (grant #5888) and the Canadian Intensive Care Foundation (CICF). AFT is the Canada Research Chair in Critical Care Neurology and Trauma. LM, LAM, AFT and RZ are or were recipients of New Investigator Awards from the Canadian Institutes of Health Research (CIHR) during the conduction of the study. AFT and FL are supported by the Traumatology Research Consortium of the FRQS. FL is a recipient of a salary support Award from the FRQS.
Competing interests None declared.
Ethics approval Centre Hospitalier Affilié Universitaire de Québec (CHAUQ) Research Ethics Board.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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