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

Abstract

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 6weeks prior to the diagnosis of VTE, and the treatment pattern during 3months after VTE diagnosis in Chinese patients hospitalized for surgeries or medical illness. 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 6weeks of VTE diagnosis and prospectively follow-up patients for 3months (in four visits). The primary outcome is to determine the percentage of patients receiving adequate prophylaxis in patients hospitalized within 6weeks before VTE diagnosis and treatment pattern within 3months 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. 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. The study is registered in the Venous Thromboembolism Registry in China with study number DIREGL07581. Sanofi China.