Huijben Jilske A, Pisica Dana, Ceyisakar Iris, Stocchetti Nino, Citerio Giuseppe, Maas Andrew I R, Steyerberg Ewout W, Menon David K, van der Jagt Mathieu, Lingsma Hester F
Center for Medical Decision Sciences, Department of Public Health, Erasmus MC-University Medical Center Rotterdam, Rotterdam, The Netherlands.
Department of Pathophysiology and Transplants, University of Milan, Milan, Italy.
Neurotrauma Rep. 2022 Jan 7;2(1):4-14. doi: 10.1089/neur.2021.0037. eCollection 2022.
The aims of this study are to describe the use of pharmaceutical venous thromboembolism (pVTE) prophylaxis in patients with traumatic brain injury (TBI) in Europe and study the association of pVTE prophylaxis with outcome. We included 2006 patients ≥18 years of age admitted to the intensive care unit from the CENTER-TBI study. VTE events were recorded based on clinical symptoms. Variation between 54 centers in pVTE prophylaxis use was assessed with a multi-variate random-effect model and quantified with the median odds ratio (MOR). The association between pVTE prophylaxis and outcome (Glasgow Outcome Scale-Extended at 6 months) was assessed at center level with an instrumental variable analysis and at patient level with a multi-variate proportional odds regression analysis and a propensity-matched analysis. A time-dependent Cox survival regression analysis was conducted to determine the effect of pVTE prophylaxis on survival during hospital stay. The association between VTE prophylaxis and computed tomography (CT) progression was assessed with a logistic regression analysis. Overall, 56 patients (2%) had a VTE during hospital stay. The majority, 1279 patients (64%), received pVTE prophylaxis, with substantial between-center variation (MOR, 2.7; < 0.001). A moderate association with improved outcome was found at center level (odds ratio [OR], 1.2 [0.7-2.1]) and patient level (multi-variate adjusted OR, 1.4 [1.1-1.7], and propensity adjusted OR, 1.5 [1.1-2.0]), with similar results in subgroup analyses. Survival was higher with the use of pVTE prophylaxis ( < 0.001). We found no clear effect on CT progression (OR, 0.9; CI [0.6-1.2]). Overall, practice policies for pVTE prophylaxis vary substantially between European centers, whereas pVTE prophylaxis may contribute to improved outcome. Trial registration number is NCT02210221 at ClinicalTrials.gov, registered on August 6, 2014 (first patient enrollment on December 19, 2014).
本研究的目的是描述欧洲创伤性脑损伤(TBI)患者中药物性静脉血栓栓塞(pVTE)预防措施的使用情况,并研究pVTE预防措施与预后的相关性。我们纳入了CENTER-TBI研究中入住重症监护病房的2006例年龄≥18岁的患者。根据临床症状记录VTE事件。采用多变量随机效应模型评估54个中心在pVTE预防措施使用方面的差异,并用中位数优势比(MOR)进行量化。在中心层面采用工具变量分析,在患者层面采用多变量比例优势回归分析和倾向匹配分析,评估pVTE预防措施与预后(6个月时的扩展格拉斯哥预后量表)之间的相关性。进行时间依赖性Cox生存回归分析,以确定pVTE预防措施对住院期间生存的影响。采用逻辑回归分析评估VTE预防措施与计算机断层扫描(CT)进展之间的相关性。总体而言,56例患者(2%)在住院期间发生了VTE。大多数患者,即1279例(64%)接受了pVTE预防,各中心之间存在显著差异(MOR,2.7;<0.001)。在中心层面(优势比[OR],1.2[0.7-2.1])和患者层面(多变量调整后的OR,1.4[1.1-1.7],倾向调整后的OR,1.5[1.1-2.0])发现与预后改善存在中度相关性,亚组分析结果相似。使用pVTE预防措施时生存率更高(<0.001)。我们未发现对CT进展有明显影响(OR,0.9;CI[0.6-1.2])。总体而言,欧洲各中心在pVTE预防措施的实践策略上存在很大差异,而pVTE预防措施可能有助于改善预后。试验注册号为ClinicalTrials.gov上的NCT02210221,于2014年8月6日注册(首例患者于2014年12月19日入组)。