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The main objective of this study is to compare the efficacy and safety of aspirin, low molecule heparin and rivaroxaban for preventing catheter-related thrombosis in middle-to-high-risk ambulatory patients with cancer and implantable venous access ports.
Study Type: Interventional, randomized, parallel Assignment and no masking
Study Arms & Intervention: Drug 1: Aspirin, 100mg/day orally; Drug 2: rivaroxaban, 10mg/day orally; Drug 3: low molecule heparin, 4000IU(0.4ml)/day subcutaneous injection; Reference: mechanical prophylaxis.
Follow-up Period: 6 months. The trial visits occurred at time before each chemotherapy cycle. The following details should be included at each visit: Khorana score, height and weight, blood routine examination, coagulation function, stool-routine and occult blood test, renal and liver function, ultrasonography of both legs and neck.
Primary Outcome: The primary efficacy end point was the occurrence of thrombus in the vein at the puncture site or nearby. The primary was the occurrence of a major bleeding event as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Secondary Outcome: The secondary efficacy end point was occurrence of occurrence of other thrombosis or embolism events like deep vein thrombosis or pulmonary embolism. The secondary safety endpoint was the occurrence of any clinically relevant non-major bleeding, minor bleeding and adverse events.
Population: patients with cancer and implantable venous access ports
Eligibility Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin 100mg | Experimental |
| |
| rivaroxaban 10mg | Experimental |
| |
| low molecule heparin | Experimental |
| |
| Reference | No Intervention | mechanical prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10mg | Drug | 10mg orally per day |
| |
| Aspirin 100mg |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of catheter-related thrombosis | detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary | from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle |
| occurrence of major-bleeding event | define occurrence of major-bleeding event with ISTH standard | from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of other thrombosis or embolism events except for catheter-related thrombosis | detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary | from enrollment to the first time of occurrence of other thrombosis or embolism events except for catheter-related thrombosis , up to 1 month after the completion of last chemotherapy cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Huang, Doctor | Contact | 13958123068 | hjys@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Huang, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the People's Hospital of Dongyang City | Not yet recruiting | Dongyang | Zhejiang | China |
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| Drug |
100mg orally per day |
|
| low molecule heparin | Drug | 0.4ml per day subcutaneous injection |
|
| 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 enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
|
| Sir Run Run Shaw Hospital, the Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| the First Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| the First Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| the First People's Hospital of Xiaoshan District, Hangzhou | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| Women's Hospital of School of Medicine Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Provincial Hospital of TCM | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Provincial Hospital of TCM | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| the Central Hospital of Huzhou City | Not yet recruiting | Huzhou | Zhejiang | China |
|
| the Second Affiliated Hospital of Jiaxing College | Not yet recruiting | Jiaxing | Zhejiang | China |
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| the Women's Hospital of Jiaxing City | Not yet recruiting | Jiaxing | Zhejiang | China |
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| the Central Hospital of Jinhua City | Not yet recruiting | Jinhua | Zhejiang | China |
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| the Central Hospital of Lishui City | Not yet recruiting | Lishui | Zhejiang | China |
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| the People's Hospital of Jinyun County | Not yet recruiting | Lishui | Zhejiang | China |
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| the People's Hospital of Lishui City | Not yet recruiting | Lishui | Zhejiang | China |
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| the People's Hospital of Lishui City | Not yet recruiting | Lishui | Zhejiang | China |
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| the Women's Hospital of Lishui City | Not yet recruiting | Lishui | Zhejiang | China |
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| the Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | China |
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| the Huamei Hospital of Ningbo City, University of Chinese Academy of Sciences | Not yet recruiting | Ningbo | Zhejiang | China |
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| the People's Hospital of Yinzhou | Not yet recruiting | Ningbo | Zhejiang | China |
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| the Women's and Children's Hospital of Ningbo City | Not yet recruiting | Ningbo | Zhejiang | China |
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| the Affiliated Hospital of Shaoxing University | Not yet recruiting | Shaoxing | Zhejiang | China |
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| the First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
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| the Second Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
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| the Zhoushan Hospital of Zhejiang Province | Not yet recruiting | Zhoushan | Zhejiang | China |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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