Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 695
- 试验地点
- 46
- 主要终点
- Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
研究概览
简要总结
The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.
The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •cancer patients with a first diagnosis of unsuspected PE
排除标准
- •age <18 years;
- •ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
- •life expectancy less than 3 months.
研究组 & 干预措施
Anticoagulants, aspirin
Parenteral or oral anticoagulants: heparin, fondaparinux, vitamin-K antagonists, direct thrombin inhibitors, direct factor Xa inhibitors; aspirin. Any dosage, frequency and duration
干预措施: Heparin, fondaparinux, vitamin-K antagonists, aspirin (Drug)
结局指标
主要结局
Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis
时间窗: one year
Suspected recurrent PE with one of the following: 1. new intra-luminal filling defect on CT scan, MRI scan, or pulmonary angiogram; 2. new perfusion defect of at least 75% on V/Q lung scan; 3. inconclusive spiral CT, pulmonary angiography or lung scan with demonstration of DVT in the lower extremities by CUS or venography Fatal PE is: 1. PE based on objective diagnostic testing or autopsy or 2. death not attributed to a documented cause and for which DVT/PE cannot be ruled out. Suspected (recurrent) DVT with one of the following findings: 1. abnormal CUS; 2. an intra-luminal filling defect on venography.
次要结局
- Major, clinically relevant non-major bleeding, and minor bleeding(one year)
研究者
Marcello Di Nisio
Principal Investigator
G. d'Annunzio University