Turgeon Alexis F, Lauzier François, Zarychanski Ryan, Fergusson Dean A, Léger Caroline, McIntyre Lauralyn A, Bernard Francis, Rigamonti Andrea, Burns Karen, Griesdale Donald E, Green Robert, Scales Damon C, Meade Maureen O, Savard Martin, Shemilt Michèle, Paquet Jérôme, Gariépy Jean-Luc, Lavoie André, Reddy Kesh, Jichici Draga, Pagliarello Giuseppe, Zygun David, Moore Lynne
Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), CHU de Québec-Université Laval Research Centre, Québec City, Québec, Canada.
Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Québec, Canada.
BMJ Open. 2017 Apr 17;7(4):e013779. doi: 10.1136/bmjopen-2016-013779.
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.
A prospective cohort study.
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.
The compliance to protocolised test procedures was the primary outcome. Secondary outcomes were enrolment rate and compliance to follow-up.
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.
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.
严重创伤性脑损伤是年轻成年人发病和死亡的重要原因。评估此类损伤后的长期神经学转归具有难度,且往往存在不确定性。本可行性研究的目的是确定开展一项大型多中心前瞻性研究以建立重症严重创伤性脑损伤患者长期神经学转归预后模型的可行性。
前瞻性队列研究。
9家加拿大重症监护病房纳入急性严重创伤性脑损伤患者。在重症监护病房的第一周系统收集临床、生物学、放射学和电生理数据。在出院时以及受伤后3、6和12个月评估死亡率和功能转归(扩展格拉斯哥预后量表)。
对标准化测试程序的依从性是主要结果。次要结果是入组率和随访依从性。
我们在12个月期间成功纳入50例患者。大多数患者为男性(80%),中位年龄45岁(四分位间距29.0 - 60.0),中位损伤严重度评分为38分(四分位间距25 - 50),格拉斯哥昏迷量表评分为6分(四分位间距3 - 7)。死亡率为38%(19/50),大多数死亡发生在决定撤除生命维持治疗后(18/19)。未纳入的主要原因是纳入的时间窗在正常工作时间之后(35%,n = 23)和疏忽(24%,n = 16)。对标准化测试程序的依从性在92%至100%之间,入组率为43%。6个月时无患者失访,12个月时有2例失访。
在这项多中心前瞻性可行性研究中,我们实现了与测试依从性、入组和随访相关的可行性目标。我们得出结论,加拿大针对严重创伤性脑损伤患者的TBI - 预后前瞻性多中心研究是可行的。