全球抗凝注册研究 - 静脉血栓栓塞症(GARFIELD-VTE)。原理与设计。

Global Anticoagulant Registry in the Field - Venous Thromboembolism (GARFIELD-VTE). Rationale and design.

机构信息

Jeffrey I. Weitz, MD, Thrombosis and Atherosclerosis Research Institute, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada, Tel: +1 905 574 8550, Fax: +1 905 575 2646, E-mail:

出版信息

Thromb Haemost. 2016 Nov 30;116(6):1172-1179. doi: 10.1160/TH16-04-0335. Epub 2016 Sep 22.

Abstract

Venous thromboembolism (VTE) is a common disorder associated with significant rates of morbidity and mortality. VTE management aims to reduce mortality, the risks of recurrence, and long-term complications. VTE treatment is evolving with the introduction of non-vitamin K antagonist anticoagulants (NOACs). The Global Anticoagulant Registry in the FIELD - Venous Thromboembolism (GARFIELD-VTE) is a prospective, multicentre, observational study that will enrol 10,000 patients treated for acute VTE from ~500 sites in 28 countries. Identified sites reflect the diversity of care settings, including hospital and outpatient settings. Patients will be managed according to local practices and followed for at least three years. The primary objective is to determine the extent to which VTE treatment varies in the real-world setting and to assess the impact of such variability on clinical and economic outcomes. Evolving patterns of care will be captured using two sequential cohorts. The GARFIELD-VTE registry will provide insights into the evolving global treatment patterns for VTE, both deep-vein thrombosis and pulmonary embolism. By enrolling patients from diverse care settings, the registry will provide information on adherence to national and international guidelines, identify good practice as well as treatment deficiencies, and relate patient outcomes to clinical management. The incidence of death, recurrent VTE, bleeding, post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension will be documented. By capturing information during and after anticoagulation treatment, the registry will not only define aspects of the natural history of VTE, but also its economic and societal impact at a regional and global level.

摘要

静脉血栓栓塞症(VTE)是一种常见的疾病,与较高的发病率和死亡率相关。VTE 的管理旨在降低死亡率、复发风险和长期并发症。随着非维生素 K 拮抗剂抗凝剂(NOACs)的引入,VTE 的治疗方法也在不断发展。全球抗凝剂登记处 - 静脉血栓栓塞症(GARFIELD-VTE)是一项前瞻性、多中心、观察性研究,将从 28 个国家约 500 个地点招募 10000 名急性 VTE 患者。确定的地点反映了护理环境的多样性,包括医院和门诊环境。患者将根据当地的实践进行管理,并至少随访 3 年。主要目的是确定真实世界环境中 VTE 治疗的差异程度,并评估这种变异性对临床和经济结果的影响。通过两个连续队列来捕获不断变化的护理模式。GARFIELD-VTE 登记处将提供有关 VTE(深静脉血栓形成和肺栓塞)全球治疗模式不断发展的见解。通过从不同的护理环境招募患者,该登记处将提供关于遵守国家和国际指南的信息,确定良好的实践以及治疗缺陷,并将患者的结果与临床管理联系起来。将记录死亡、复发性 VTE、出血、血栓后综合征和慢性血栓栓塞性肺动脉高压的发生率。通过在抗凝治疗期间和之后捕获信息,该登记处不仅将定义 VTE 的自然史的各个方面,还将定义其在区域和全球范围内的经济和社会影响。

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