Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
Study NCT ID:
NCT06149533
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
A Randomized, Multicenter, Open-Label, Control, Clinical Trial to Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Thrombosis
Brief Summary:
To evaluate the efficacy and safety of edoxaban in the prevention of tumor catheter-related thrombosis (CVC/PICC) in high-risk patients
Detailed Description:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: