NCT06443905

Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients

Efficacy, Safety and Cost-effectiveness of Xueshuantong Injection (Lyophilized) in the Prevention of Venous Thromboembolism (VTE) in Hospitalized Patients at Risk of Bleeding: a Real-world Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 21,600 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy, safety and cost-effectiveness of Xueshuantong (lyophilized) for the prevention of venous thromboembolism (VTE) in patients at risk of bleeding.

Detailed description

This is a non-randomized, observational study. This study primarily aims to investigate the efficacy, safety, and cost-effectiveness of using Xueshuantong injection (lyophilized) for preventing venous thromboembolism (VTE) in patients susceptible to bleeding. The subjects of the study comprise patients during the perioperative period (undergoing procedures lasting 45 minutes or longer), patients with a confirmed spontaneous cerebral hemorrhage (ICH), and patients with a confirmed acute ischemic stroke (AIS). Additional objectives of this study including: 1. to evaluate the possible dose-dependency of Xueshuantong injection (lyophilized); 2. to evaluate the impact in coagulation function after administration of Xueshuantong injection (lyophilized)

Conditions

• Venous Thromboembolism (VTE)
• Thromboembolism

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2024-06-05
• Last updated: 2024-06-05

Locations

14 sites across 1 country: China