Edoxaban for prevention of catheter-related thrombosis in cancer patients: a randomized, multicenter, open-label, control, clinical trail

Background The central venous catheter (CVC) brings convenience to cancer patients while also introducing some complications, among which catheter-related thrombosis (CRT) is common. CRT affects the use of the catheter and can even lead to serious complications. How to prevent the occurrence of CRT is an important solution to this problem. However, there is currently no definitive recommended protocol for preventing CRT. Methods This study was a prospective, interventional, open, randomized controlled clinical study. A total of 366 patients with cancers who will be assessed as high risk by the thrombosis risk prediction model are planned to be enrolled. All patients are planned to undergo antitumor chemotherapy and receive a peripherally inserted central catheter and a CVC catheterization on the first day of chemotherapy. The patients will be randomly divided into the experimental group and the control group at a ratio of 1:1. The experimental group will be treated with edoxaban to prevent CRT and the control group will not be treated with edoxaban. Venous vascular ultrasound will be conducted before the start of each cycle of chemotherapy or whenever patients have any thrombosis-related symptoms to assess whether they have CRT. The purpose is to explore the preventive effect of X-factor inhibitor edoxaban on CRT. The primary endpoint is the incidence of CRT during catheterization. Discussion This study can benefit cancer patients by reducing the incidence of CRT and preventing further damage caused by thrombosis. At the same time, it can improve the quality of life for patients and reduce medical expenses due to thrombosis. Additionally, this study can further explore the factors that influence the occurrence of CRT. To our knowledge, this is the first clinical study focusing on the primary prevention of CRT.