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Identification of Chinese Hospitalized Patients’ Risk Profile for Venous Thromboembolism (DissolVE1): A Study Protocol of a Non-Interventional Registry Study

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Abstract

Introduction

Venous thromboembolism (VTE) is a frequent cause of hospitalization, mortality, and long-term adverse consequence among medical and surgical inpatients. The current study is performed to identify the prophylaxis of patients with VTE risk within the 6 weeks prior to the diagnosis of VTE, and the treatment pattern during 3 months after VTE diagnosis in Chinese patients hospitalized for surgeries or medical illness.

Methods

This multicenter, non-interventional, observational registry plans to enroll 1200 patients from 40 centers in China. The study will retrospectively collect data from patients’ hospitalization record within 6 weeks of VTE diagnosis and prospectively follow-up patients for 3 months (in four visits). The primary outcome is to determine the percentage of patients receiving adequate prophylaxis in patients hospitalized within 6 weeks before VTE diagnosis and treatment pattern within 3 months after VTE diagnosis. Important secondary endpoints include determining patients with risk of VTE in the hospital setting, risk factors for VTE, and cost analysis of VTE treatment.

Expected Outcomes

The findings will determine the characteristics of VTE, its treatment practices, cost of treatment, and quality of life in patients; this information may help in building diagnostic and prophylaxis strategies for VTE in China.

Trial Registration

The study is registered in the Venous Thromboembolism Registry in China with study number DIREGL07581.

Funding

Sanofi China.

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Abbreviations

CI:

Confidence interval

CRF:

Case report form

DVT:

Deep vein thrombosis

EDC:

Electronic data capture

FAS:

Full analysis set

HIT:

Heparin-induced thrombocytopenia

PE:

Pulmonary embolism

SD:

Standard deviation

VTE:

Venous thromboembolism

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Acknowledgements

We thank the participants of the study.

Funding

This study is sponsored and funded by Sanofi China. Sanofi China also funded the article processing charges for this work. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing and Editorial Assistance

The authors would like to thank Dr Amit Bhat and Dr Vedashree Sobagaiah (Indegene, Bangalore, India) for providing the necessary writing assistance and editorial support during development of the manuscript as funded by Sanofi China.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

LX and YY conceived and designed the study. YY, TP, and ZZ bear overall responsibility for the design, ethical conduct, publication of the study, administrative, technical, and material support, study data gathering and verification. All authors edited the draft and contributed substantially to the manuscript; they all approved this submission.

Disclosures

Yang Yuanhua, Tang Peifu, Zhai Zhenguo, and Li Xiaoying declare that they have no conflict of interest.

Compliance with Ethics Guidelines

This study will be approved by the medical ethics committees of the included centers (Supplementary Table 1) with written informed consent from the participants as indicated in the Declaration of Helsinki (1964) and its subsequent revisions. This manuscript does not contain any personal medical information about an identifiable living individual. Data from participants of this study will be anonymized.

Trial Registration

Venous Thromboembolism Registry in China (China VTE registry). Study number: DIREGL07581, Study name: DissolVE1, Version date: Approval date (07-Jul-2016).

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Author information

Authors and Affiliations

  1. Beijing Chao-Yang Hospital, Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China

    Yang Yuanhua

  2. Chinese PLA General Hospital, Haidian District, Beijing, China

    Tang Peifu & Li Xiaoying

  3. National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Yinghua Dongjie, Hepingli, Beijing, China

    Zhai Zhenguo

Authors
  1. Yang Yuanhua
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  2. Tang Peifu
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  3. Zhai Zhenguo
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  4. Li Xiaoying
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Corresponding author

Correspondence to Li Xiaoying.

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Yuanhua, Y., Peifu, T., Zhenguo, Z. et al. Identification of Chinese Hospitalized Patients’ Risk Profile for Venous Thromboembolism (DissolVE1): A Study Protocol of a Non-Interventional Registry Study. Adv Ther 36, 2180–2190 (2019). https://doi.org/10.1007/s12325-019-00987-6

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