To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC/PICC) in high-risk patients
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 (refer to Appendix 1) are planned to be enrolled. All patients are planned to undergo anti-tumor chemotherapy and receive CVC or PICC catheterization on the first day of chemotherapy. The patients are randomly divided into the experimental group and the control group at a ratio of 1:1. The experimental group is treated with edoxaban to prevent catheter-related thrombosis, and the control group won't 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 catheter-related thrombosis. The incidence of catheter-related thrombosis during catheter. 1. The safety of edoxaban.2. The death caused by catheter-related thrombosis.3. The time of non thrombotic events.4. The incidence of venous thrombosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
366
Edoxaban, an oral selective factor Xa inhibitor, had been approved by the National Medical Products Administration in 2018. It is used for the treatment and recurrence prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adults.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
The incidence of catheter-related thrombosis during catheter
Time frame: 6 months
The incidence of bleeding caused by edoxaban
The incidence of bleeding caused by edoxaban including major bleeding, clinically relevant non-major bleeding and minor bleeding. The criteria is shown in Appendix 3.
Time frame: 6 months
The mortality rate caused by catheter-related thrombosis
Time frame: 6 months
The time of non thrombotic events
Time frame: 6 months
The incidence of venous thrombosis
Time frame: 6 months
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