TY - JOUR
T1 - Prognostication in critically ill patients with severe traumatic brain injury
T2 - The TBI-Prognosis multicentre feasibility study
AU - for the TBI-Prognosis Study Team and the Canadian Critical Care Trials Group
AU - Turgeon, Alexis F.
AU - Lauzier, François
AU - Zarychanski, Ryan
AU - Fergusson, Dean A.
AU - Léger, Caroline
AU - McIntyre, Lauralyn A.
AU - Bernard, Francis
AU - Rigamonti, Andrea
AU - Burns, Karen
AU - Griesdale, Donald E.
AU - Green, Robert
AU - Scales, Damon C.
AU - Meade, Maureen O.
AU - Savard, Martin
AU - Shemilt, Michèle
AU - Paquet, Jérôme
AU - Gariépy, Jean Luc
AU - Lavoie, André
AU - Reddy, Kesh
AU - Jichici, Draga
AU - Pagliarello, Giuseppe
AU - Zygun, David
AU - Moore, Lynne
N1 - Funding Information:
This study was funded by the Fonds de la Recherche du Québec-Santé (FRQS) (grant #5888) and the Canadian Intensive Care Foundation (CICF).
Publisher Copyright:
© Published by the BMJ Publishing Group Limited.
PY - 2017/4/1
Y1 - 2017/4/1
N2 - 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.
AB - 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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U2 - 10.1136/bmjopen-2016-013779
DO - 10.1136/bmjopen-2016-013779
M3 - Article
C2 - 28416497
AN - SCOPUS:85018752502
SN - 2044-6055
VL - 7
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e013779
ER -