Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 27
- 主要终点
- venous thromboembolic events
研究概览
简要总结
Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.
详细描述
Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Social security affiliation
- •Written informed consent
- •Histologically confirmed stage IV (M1a or M1b) non-small-cell lung cancer, including recurrent non-small-cell lung cancer after a period of complete remission
- •D-dimer > 1,500 µg/L
- •First line of systemic cancer treatment (chemotherapy, immunotherapy or targeted therapy), or new line of systemic cancer treatment for cancer progression (chemotherapy, immunotherapy or targeted therapy), introduced during the month preceding inclusion or planned within one month after inclusion
- •ECOG (Eastern Cooperative Oncology Group) score 0-2
- •Life expectancy >3 months
排除标准
- •Hypersensitivity to heparin or to any excipients
- •Septic endocarditis
- •History of heparin-induced thrombocytopenia
- •Ongoing anticoagulant treatment at therapeutic dosage
- •VTE at inclusion
- •Creatinin clearance <30 mL/min
- •Active bleeding
- •Platelet count < 100 G/L at inclusion
- •Severe hepatic insufficiency
- •Cancer treated exclusively with supportive care
- •Aspirin at daily dosage > 160 mg
- •Pregnancy
- •Patient under tutorship or curatorship
研究组 & 干预措施
Experimental
tinzaparin sodium
干预措施: Tinzaparin Sodium (Drug)
结局指标
主要结局
venous thromboembolic events
时间窗: 6 months
All venous thromboembolism (VTE) events during the six-month treatment period including: * objectively confirmed symptomatic pulmonary embolism (PE), * objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis), * objectively confirmed symptomatic upper extremity DVT, * objectively confirmed incidentally diagnosed PE or proximal DVT * death due to PE.
次要结局
- Venous thromboembolic events(12 months)
- Symptomatic VTE events(6 months)
- Major bleedings(6 months)
- Death(12 months)