Dreijer Albert R, Kruip Marieke J H A, Diepstraten Jeroen, Polinder Suzanne, Brouwer Rolf, Leebeek Frank W G, Vulto Arnold G, van den Bemt Patricia M L A
Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.
Department of Hospital Pharmacy, Reinier de Graaf Hospital, Delft, The Netherlands.
BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537.
Antithrombotic therapy carries high risks for patient safety. Antithrombotics belong to the top 5 medications involved in potentially preventable hospital admissions related to medication. To provide a standard for antithrombotic therapy and stress the importance of providing optimal care to patients on antithrombotic therapy, the Landelijke Standaard Ketenzorg Antistolling (LSKA; Dutch guideline on integrated antithrombotic care) was drafted. However, the mere publication of this guideline does not guarantee its implementation. This may require a multidisciplinary team effort. Therefore, we designed a study aiming to determine the influence of hospital-based antithrombotic stewardship on the effect and safety of antithrombotic therapy outcomes during and after hospitalisation.
In this study, the effect of the implementation of a multidisciplinary antithrombotic team is compared with usual care using a pre-post study design. The study is performed at the Erasmus University Medical Center Rotterdam and the Reinier de Graaf Hospital Delft. Patients who are or will be treated with antithrombotics are included in the study. We aim to include 1900 patients, 950 in each hospital. Primary outcome is the proportion of patients with a composite end point consisting of ≥1 bleeding or ≥1 thrombotic event from the beginning of antithrombotic therapy (or hospitalisation) until 3 months after hospitalisation. Bleeding is defined according to the International Society of Thrombosis and Haemostasis (ISTH) classification. A thrombotic event is defined as any objectively confirmed arterial or venous thrombosis, including acute myocardial infarction or stroke for arterial thrombosis and deep venous thrombosis or pulmonary embolism or venous thrombosis. An economic evaluation is performed to determine whether the implementation of the multidisciplinary antithrombotic team will be cost-effective.
This protocol was approved by the Medical Ethical Committee of the Erasmus University Medical Center. The findings of the study will be disseminated through peer-reviewed journals and presented at relevant conferences.
NTR4887; pre-results.
抗栓治疗对患者安全具有高风险。抗栓药物属于与潜在可预防的药物相关住院治疗有关的前5种药物。为了提供抗栓治疗标准并强调为接受抗栓治疗的患者提供最佳护理的重要性，制定了《荷兰综合抗栓护理指南》（LSKA）。然而，仅仅发布该指南并不能保证其得到实施。这可能需要多学科团队的努力。因此，我们设计了一项研究，旨在确定基于医院的抗栓管理对住院期间及出院后抗栓治疗效果和安全性结果的影响。
在本研究中，采用前后对照研究设计，将多学科抗栓团队的实施效果与常规护理进行比较。该研究在鹿特丹伊拉斯姆斯大学医学中心和代尔夫特的莱尼尔·德·格拉夫医院进行。正在或将要接受抗栓治疗的患者纳入研究。我们的目标是纳入1900名患者，每家医院950名。主要结局是从抗栓治疗开始（或住院）至出院后3个月出现由≥1次出血或≥1次血栓形成事件组成的复合终点的患者比例。出血根据国际血栓与止血学会（ISTH）分类进行定义。血栓形成事件定义为任何经客观证实的动脉或静脉血栓形成，包括动脉血栓形成的急性心肌梗死或中风以及静脉血栓形成的深静脉血栓形成、肺栓塞或静脉血栓形成。进行经济评估以确定多学科抗栓团队的实施是否具有成本效益。
本方案已获得伊拉斯姆斯大学医学中心医学伦理委员会的批准。该研究的结果将通过同行评审期刊进行传播，并在相关会议上发表。
NTR4887；预结果。
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