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The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban 10mg daily | Experimental | orally, 10 mg once daily for day1 and day 2 after femoral venepuncture |
|
| Rivaroxaban 20mg daily | Experimental | orally, 10 mg twice daily for day1 and day 2 after femoral venepuncture |
|
| Low-molecular-weight heparin | Active Comparator | subcutaneously, 0.4 ml once daily, before femoral venepuncture (day1) and after the day of femoral venepuncture (day 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG | Drug | Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of deep venous thrombosis | the incidence of deep venous thrombosis of the legs by the systematic examinations performed at the end of the 4-week after femoral venepuncture | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v 3.0 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital | Beijing | 100038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30903459 | Derived | Wang X, Wang S, Morse MA, Jiang N, Zhao Y, Song Y, Zhou L, Huang H, Zhou X, Hobeika A, Ren J, Lyerly HK. Prospective randomized comparative study on rivaroxaban and LMWH for prophylaxis of post-apheresis thrombosis in adoptive T cell immunotherapy cancer patients. J Thromb Thrombolysis. 2019 May;47(4):505-511. doi: 10.1007/s11239-019-01844-7. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Rivaroxaban 20 MG | Drug | Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture |
|
| Low-molecular-weight heparin | Drug | 0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2) |
|
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |