The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,640
- 试验地点
- 24
- 主要终点
- occurrence of catheter-related thrombosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Aspirin 100mg
干预措施: Aspirin 100mg (Drug)
rivaroxaban 10mg
干预措施: Rivaroxaban 10mg (Drug)
low molecule heparin
干预措施: low molecule heparin (Drug)
结局指标
主要结局
occurrence of catheter-related thrombosis
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)