Association Between Thrombin Generation Parameters and the Risk of Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis (CAT) (a Multicenter Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- The measurement of the area under the curve ( endogenious thrombin potential) nMxmin
研究概览
简要总结
Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.
详细描述
Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Existing models for predicting anticoagulant associated bleeding risk applied to the CAT patients are not very predictive (AUC<0.60). Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators wish to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with active cancer, as defined by current French recommendations (Mahé I et al Rev Mal Respir 2021)
- •Presenting acute proximal deep vein thrombosis of the lower limb (DVT) and/or proximal pulmonary embolism (at least segmental) (PE), confirmed by objective tests (Doppler ultrasound in the event of DVT; lung scintigraphy or CT scan in the event of PE)
- •No contraindication for anticoagulant treatment at a curative dose at the time of inclusion
排除标准
- •Patients participating in a therapeutic clinical trial with a blinded therapy or an open-label therapeutic trial who are included in the experimental treatment group.
- •Patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease
- •Hematological malignancies
- •Patients with a contraindication to anticoagulant treatment on inclusion
- •Patient whose relay by DOAC has already been carried out.
研究组 & 干预措施
Patients with cancer associated thrombosis under curative anticoagulant treatment
Patients with cancer associated thrombosis under curative anticoagulant treatment.
干预措施: Thrombin Generation Assay (TGA) (Biological)
结局指标
主要结局
The measurement of the area under the curve ( endogenious thrombin potential) nMxmin
时间窗: during the first 6 months of treatment
The measurment of the endogenious thrombin potential, during the first 6 months of treatment
the measurement of the lag time unit = seconds
时间窗: during the first 6 months of treatment
the measurement of the lag time, during the first 6 months of treatment
the measurement of the peak height unit = nm
时间窗: during the first 6 months of treatment
the measurement of the peak height during the first 6 months of treatment.
the measurement of the time to peak unit = seconds
时间窗: during the first 6 months of treatment
the mesearurement of the time to peak, during the first 6 months of treatment.
次要结局
- Occurrence of an event of interest under treatment(Month : 1 to 6)
- Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT(Month 1; Month 6)
- Effect of adding TGT results on the performance of bleeding risk prediction scores(Month 1; Month 6)