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Rivaroxaban has been developed in the various clinical settings.Although cancer-associated DVT or PE was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. In this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.Therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rivaroxaban | Experimental | oral Rivaroxaban 10mg per day for 90days |
|
| blank control | No Intervention | mechanical prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban | Drug | Rivaroxaban 10mg orally per day for 90days |
|
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of venous thrombosis | detect the occurrence of venous thrombosis with ultrasound, venography if necessary. | From date of randomization until the date of occurrence of thrombosis or date of death from any cause, whichever came first, assessed up to 6 months |
| occurrence of a major bleeding event. | define occurrence of major-bleeding event with ISTH standard | From date of randomization until the date of occurrence of a major bleeding event or date of death from any cause, whichever came first, assessed up to 6 months |
| occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event | define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0 | From date of randomization until the date of occurrence of events or date of death from any cause, whichever came first, assessed up to 6 months |
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Eligibility Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liu ting, master | Contact | 13978872445 | liuting201070176@163.com | |
| yu bin, PHD | Contact | 13877253868 | 95197586@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| yu bin, PHD | LiuZhou People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30786186 | Background | Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630. | |
| 31353841 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Background |
| Wang TF, Zwicker JI, Ay C, Pabinger I, Falanga A, Antic D, Noble S, Khorana AA, Carrier M, Meyer G. The use of direct oral anticoagulants for primary thromboprophylaxis in ambulatory cancer patients: Guidance from the SSC of the ISTH. J Thromb Haemost. 2019 Oct;17(10):1772-1778. doi: 10.1111/jth.14564. Epub 2019 Jul 28. No abstract available. |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |