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Comparison of the outcomes of warfarin therapy and economics by online and offline anticoagulation management models: protocol for a randomised controlled trial

医学 华法林 协议(科学) 随机对照试验 知情同意 临床试验 人口 家庭医学 物理疗法 替代医学 内科学 心房颤动 环境卫生 病理
作者
Xiaotong Xia,Jinglan Fu,Tingting Wu,Wenjun Chen,Jinhua Zhang
出处
期刊:BMJ Open [BMJ]
卷期号:9 (9): e031730-e031730 被引量:4
标识
DOI:10.1136/bmjopen-2019-031730
摘要

Introduction Warfarin is widely used in the world as oral anticoagulant, but it is difficult to manage patients after medication due to its narrow treatment window and individualised differences. Therefore, every region uses network means to carry out online anticoagulant therapy services. The purpose of this paper is to compare monitoring results and randomised controlled studies of the complications of warfarin treated by offline or online management in a Chinese population. Methods and analysis This is a randomised controlled, multicentre clinical trial. Taking the Union Hospital Affiliated to Fujian Medical University as the main centre, a randomised controlled study of several subcentres around China produced a nationally representative sample. 496 participants who took warfarin will be recruited and then randomly divided into two groups at a ratio of 1:1. We will collect data on patient characteristics, diagnosis, treatment, hospitalisation results and later complications. Ethics and dissemination The study was approved by the Ethics Committee of the Union Hospital Affiliated to Fujian Medical University. All cooperative hospitals have been approved by the Central Ethics Committee. The results of the survey will be disseminated in future peer review documents and will provide the basis for a management model for patients in China taking warfarin. Trial registration number ChiCTR1900021920.

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