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New warfarin anticoagulation management model after heart valve surgery: rationale and design of a prospective, multicentre, randomised trial to compare an internet-based warfarin anticoagulation management model with the traditional warfarin management model
  1. Zhihui Zhu,
  2. Yuehuan Li,
  3. Xu Meng,
  4. Jie Han,
  5. Yan Li,
  6. Kun Liu,
  7. Jinglun Shen,
  8. Ying Qin,
  9. Haibo Zhang
  1. Beijing Anzhen Hospital, Capital Medical University, Beijing, China
  1. Correspondence to Dr Haibo Zhang; zhanghb2318{at}163.com

Abstract

Introduction Warfarin is an effective anticoagulant and the only oral anticoagulant available for patients with mechanical heart valves. The prothrombin time and the associated international normalised ratio (INR) are routinely tested to monitor the response to anticoagulation therapy in patients. Patients who undergo mechanical heart valve replacement need lifelong anticoagulation therapy, and their INR is regularly measured to adjust the anticoagulation strength and the dose of anticoagulation drugs. Appropriate warfarin anticoagulation management can reduce patient complications, such as bleeding and thrombosis, and improve the long-term survival rate. We propose modern internet technology as a platform to build a warfarin anticoagulation follow-up system after valve replacement surgery. This system will provide doctors and patients with more standardised and safer follow-up methods as well as a method to further reduce the risk of warfarin anticoagulation-related complications and improve its therapeutic effects.

Methods and analysis A prospective, multicentre, randomised, controlled trial will be conducted. A total of 700 patients who require long-term warfarin anticoagulation monitoring after heart valve replacement will be enrolled and randomly divided at a 1:1 ratio into a traditional outpatient anticoagulation management group and a group undergoing a new method of management based on the internet technology with follow-up for 1 year. Differences in the percentage of time in the therapeutic range (TTR), drug dose adjustments, bleeding/thrombosis and other related complications will be observed. The primary endpoint is the difference in the TTR between the two groups. The purpose of this study is to explore a safer and more effective mode of doctor–patient interaction and communication in the internet era. As of 13 July 2019, 534 patients had been enrolled.

Ethics and dissemination This study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. The results will be published in a peer-reviewed medical journal.

Trial registration number ChiCTR1800016204.

  • mechanical valve replacement
  • follow-up
  • anticoagulation
  • telemedicine

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors HZ, ZZ and YL conceived the study idea. YQ, JH, YL, XM, JS and KL made substantial contributions to the development of the study protocol. ZZ drafted the manuscript, and all the authors contributed to the critical revisions of the paper. The final manuscript was read and approved by all the authors.

  • Funding The work is supported by the Beijing Science and Technology Commission of China (New warfarin anticoagulation management model after heart valve surgery, grant number: D171100002917003).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study protocol was approved by the Ethics Committee of Beijing Anzhen Hospital, Capital Medical University. The approved study protocol and related materials, such as consent forms and CRFs, have been submitted to the participating centres. Ethics approval was obtained from the ethics committees of all participating centres. All centres received institutional review board approval from their own ethics committees or accepted approval from the central ethics committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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