Anti Xa Activity in Cancer Patients Receiving Low-molecular-weight Heparin for Venous Thromboembolism
试验速览
- 阶段
- 不适用
- 入组人数
- 370
- 试验地点
- 8
- 主要终点
- anti-Xa activity
研究概览
简要总结
Low molecular weight heparins (LMWH) are the reference molecule for the long term treatment of venous thromboembolism (VTE) in cancer patients but remains, however, associated with a high risk of recurrent thromboembolism. The high rate of recurrence may result from alterations in the pharmacokinetics of LMWH. The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE). The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
详细描述
Purpose of the study:
The primary purpose of the study is to compare the pharmacokinetics of anti-Xa activity in patients with cancer and patients without cancer treated with curative dose of low molecular weight heparins (LMWH) for venous thromboembolism (VTE).
The secondary purposes are 1/ to study the correlation between anti-Xa LMWH and concentration of plasma heparanase and 2/ to evaluate the predictive nature of the anti-Xa activity on the occurrence of thromboembolic recurrence in cancer patients treated with LMWH for VTE.
Study design:
Multicentre cohort study of patients hospitalized with VTE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Being affiliated to a social security scheme
- •Having an active solid or hematological cancer (myeloma or lymphoma), histologically or cytologically confirmed, for which the active state will be defined by the existence of a tumoral active disease or an incomplete tumoral resection or the persistence of high tumor markers after complete resection of the tumor.
- •The venous thromboembolism disease has to be:
- •A deep vein thrombosis of lower extremity (proximal or distal) confirmed by the lack of compressibility of a venous segment under the ultrasound probe or the presence of a venous gap in CT venography or phlebography;
- •or a thrombosis of the vena cava or the iliac vein confirmed by an abdominal CT scan with contrast or a venous ultrasound or an ilio-cavography;
- •or a pulmonary embolism confirmed according to the guidelines of the European Society of Cardiology : through a gap in a pulmonary artery, at least segmental or multiple gaps sub-segmental on spiral CT angiography of the pulmonary arteries or by a high appearance probability on a lung radionuclide imaging, or by clinical symptoms of pulmonary embolism accompanying symptomatic proximal vein thrombosis confirmed by a venous ultrasound or by an unexplained echocardiography acute pulmonary heart in presence of a high clinical probability and for patients who are unfit for transport and with cardiogenic shock
- •The venous thromboembolism disease can be asymptomatic or incidentally discovered but is confirmed objectively.
- •No cons-indication to low molecular weight heparin treatment at therapeutic dose.
- •Prescription in the last 72 hours of a low molecular weight heparin treatment or fondaparinux at therapeutic dose.
- •Being affiliated to a social security scheme.
- •Being free from malignant tumor pathology detectable at the time of inclusion.
- •Being afflicted with venous thromboembolism defined by the same criteria of cancer subjects.
- •The venous thromboembolism disease can be asymptomatic or incidentally discovered but is confirmed objectively.
- •No cons-indication to low molecular weight heparin treatment at therapeutic dose.
- •Prescription in the last 72 hours of a low molecular weight heparin treatment or fondaparinux at therapeutic dose.
排除标准
- •Visceral vein thrombosis of the upper limb or venous thrombosis of the superior vena cava system because their scalability under treatment, including the risk of embolic recurrence is less known that pulmonary embolism and thrombosis of the lower limbs and their diagnostic modalities are less formalized.
- •Tumor disease not confirmed histologically or cytologically.
- •Follow-up after complete tumor resection without elevated tumor markers.
- •Cons-indication to low molecular weight heparin treatment at therapeutic dose.
- •Initial treatment with another anticoagulant molecule than LMWH or fondaparinux (thrombin inhibitor, direct factor Xa inhibitors)
- •Severe renal impairment defined by a creatinine clearance below than 30 ml / min at baseline.
- •Known pregnancy or lack of effective contraception for women of childbearing age or breastfeeding.
- •Patient previously included in the study.
- •Impossible follow-up.
- •Life expectancy less than 6 months.
- •Patient whose weight is greater than 100 Kg.
- •Not yet confirmed suspected malignant tumor pathology associated with the venous thromboembolism disease.
- •Active cancer in the last 2 years.
- •Cons-indication to low molecular weight heparin treatment at therapeutic dose.
- •Initial treatment with another anticoagulant molecule than LMWH or fondaparinux (thrombin inhibitor, direct factor Xa inhibitors)
- •Severe renal impairment defined by a creatinine clearance below than 30 ml / min at baseline.
结局指标
主要结局
anti-Xa activity
时间窗: 10 days
The measurement of anti-Xa activity will be performed four times during the initial treatment for each patient (or during the first 5 to 10 days of treatment) and will establish pharmacokinetic modeling (population type approach, nonlinear model mixed-effect) of the low molecular weight heparin therapy in subjects with cancer or not. In order to obtain a curve of relevant anti-Xa activity.
次要结局
- all cause mortality(6 months)
- hemorrhage(6 months)
- thromboembolic recurrences(6 months)