Prophylactic Anticoagulation for Catheter-related Thrombosis
- Conditions
- Venous Thrombosis Due to Central Venous Access Device (Disorder)Patients With TumorProphylactic Anticoagulation
- Interventions
- Registration Number
- NCT04256525
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
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:
1. Age 18-75 years;
2. Patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
3. Eastern Cooperative Oncology Group (ECOG) class 0-1;
4. Expected to receive chemotherapy within 1 week of enrollment;
5. Expected survival of more than 6 months;
6. Ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
7. Khorana score 1-3 point.
Exclusion Criteria:
1. Patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;
2. Patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke;
3. moderate to severe liver and kidney dysfunction;
4. pregnant or lactating women;
5. patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
6. Patients taking methotrexate;
7. Patients with systemic use of non-steroidal anti-inflammatory drugs;
8. Patients who have had anticoagulant drugs for any other reason.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1640
- age 18-75 years;
- patients with malignant tumors who received implantable drug delivery devices as intravenous access for systematic chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) class 0-1;
- expected to receive chemotherapy within 1 week of enrollment;
- expected survival of more than 6 months;
- ambulatory patients or outpatient chemotherapy patients whose intravenous chemotherapy less than 24 hours per hospital stay;
- Khorana score 1-3 point.
- patients with a history of allergies to low molecular weight heparin, rivaroxaban, aspirin or other non-steroidal anti-inflammatory drugs, especially those with asthma, neurovascular edema or shock;
- patients with bleeding risks: thrombocytopenia (platelet count < 50*109/L), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke;
- moderate to severe liver and kidney dysfunction;
- pregnant or lactating women;
- patients who are administered systemically with pyrrole-antimycotic agents (eg ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (eg ritonavir);
- patients taking methotrexate;
- patients with systemic use of non-steroidal anti-inflammatory drugs;
- patients who have had anticoagulant drugs for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin 100mg Aspirin 100mg - low molecule heparin low molecule heparin - rivaroxaban 10mg Rivaroxaban 10mg -
- Primary Outcome Measures
Name Time Method occurrence of catheter-related thrombosis from enrollment to the first time of occurrence of catheter-related thrombosis, up to 1 month after the completion of last chemotherapy cycle detect the occurrence of catheter-related thrombosis with ultrasound, venography if necessary
occurrence of major-bleeding event from enrollment to the first time of occurrence of major-bleeding event, up to 1 month after the completion of last chemotherapy cycle define occurrence of major-bleeding event with ISTH standard
- Secondary Outcome Measures
Name Time Method occurrence of clinically relevant non-major-bleeding, minor-bleeding or non-bleeding event from enrollment to the first time of occurrence of events, up to 1 month after the completion of last chemotherapy cycle define occurrence of non-major-bleeding or minor-bleeding event with ISTH standard, evaluate the relevant adverse drug reaction with NCI CTCAE 5.0
occurrence of other thrombosis or embolism events except for catheter-related thrombosis 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 detect deep vein thrombosis with ultrasound for the lower extremity, , ultrasound for the upper extremity, pulmonary arteriography or venography if necessary
Trial Locations
- Locations (24)
the First People's Hospital of Xiaoshan District, Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
the Central Hospital of Jinhua City
🇨🇳Jinhua, Zhejiang, China
the Huamei Hospital of Ningbo City, University of Chinese Academy of Sciences
🇨🇳Ningbo, Zhejiang, China
the Affiliated Hospital of Shaoxing University
🇨🇳Shaoxing, Zhejiang, China
the People's Hospital of Lishui City
🇨🇳Lishui, Zhejiang, China
the People's Hospital of Jinyun County
🇨🇳Lishui, Zhejiang, China
the First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
the Zhoushan Hospital of Zhejiang Province
🇨🇳Zhoushan, Zhejiang, China
the Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
the Central Hospital of Huzhou City
🇨🇳Huzhou, Zhejiang, China
the People's Hospital of Dongyang City
🇨🇳Dongyang, Zhejiang, China
Sir Run Run Shaw Hospital, the Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Women's Hospital of School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
the Women's Hospital of Jiaxing City
🇨🇳Jiaxing, Zhejiang, China
Zhejiang Provincial Hospital of TCM
🇨🇳Hangzhou, Zhejiang, China
the Affiliated Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
the People's Hospital of Yinzhou
🇨🇳Ningbo, Zhejiang, China
the Central Hospital of Lishui City
🇨🇳Lishui, Zhejiang, China
the Women's and Children's Hospital of Ningbo City
🇨🇳Ningbo, Zhejiang, China
the Second Affiliated Hospital of Jiaxing College
🇨🇳Jiaxing, Zhejiang, China
the Women's Hospital of Lishui City
🇨🇳Lishui, Zhejiang, China