Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Identification of the Most Relevant Risk Factors for Thromboembolism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of incidents
研究概览
简要总结
Non interventional multi-centric study that will aim in evaluating the efficacy and safety of Fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for Thromboembolism.
详细描述
Non interventional multi-centric study that will aim in evaluating the efficacy and safety of Fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for Thromboembolism.
It is a cohort study, recruiting cancer patients over 18 years of age, who have been diagnosed with cancer for over a period of one year.
Exclusion criteria apply as well while all patients can withdraw their participation at any time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Upcoming surgery for newly diagnosed or potential cancer or relapse / metastasis of cancer that has been treated and diagnosed ≥ 1 year
排除标准
- •Recent (<6 months) episode of venous thromboembolic disease (Deep vein thrombosis and / or pulmonary embolism and / or thrombosis in a rare location such as visceral or cerebral venous thrombosis)
- •Pregnancy or pregnancy
- •Patients on long-term anticoagulation for any reason (MKH, HMB or ABK, DOACs) at prophylactic or therapeutic dose, prior to enrollment in the study.
- •Active haemorrhage, diagnosed hemorrhagic disorder, thrombocytopenia
- •Ulcers or vasodilatations of the gastrointestinal tract
- •Hemorrhagic stroke or surgery in the brain, spine or eye of the last trimester
- •Bacterial endocarditis or other contraindication to the use of anticoagulant treatment
- •Creatinine clearance <20mL / min
- •Thrombolytic treatment or administration of dextran in the 2 days preceding administration of fondaparinux
结局指标
主要结局
Number of incidents
时间窗: One Year
Observed number of incidents per cancer type
Number of bleeding episodes
时间窗: One Year
The incidence of bleeding episodes by type of cancer
Comparison of results/incidents among groups
时间窗: One Year
Results of treatment in subgroups of patients (for example patients with newly diagnosed cancer or potential cancer or relapse / metastasis of cancer that has been treated before and diagnosed ≥ 1 year)
Evaluation
时间窗: One Year
Evaluation of antithrombotic treatment
次要结局
未报告次要终点