Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of thrombotic events
研究概览
简要总结
During MeTHOS study will be collected Real World Data the clinical practice regarding Thromboprophylaxis in high thrombotic risk solid tumors patients undergoing surgical and /or chemotherapeutical treatment, for one year following the protocol initiation date.
Specifically focus will be on the following:
- Number of thrombotic events
- Anti-thrombotic management dosage & duration
- Any bleedings related to anticoagulation
- Patients' adherence and compliance
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
- •Patients who were diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Life expectancy >6 months
- •Signed informed consent
- •Exclusion Criteria
- •Patients who were not diagnosed with histological confirmed high thrombotic risk cancers (GI, thoracic, gynecologic and genitourinary) undergoing surgery
- •Age < 18 years
- •ECOG performance status >2
- •Life expectancy <6 months
- •Not signed informed consent
排除标准
- 未提供
结局指标
主要结局
Number of thrombotic events
时间窗: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Measure the number of thrombotic events in the population
Number of bleedings related to anticoagulation
时间窗: Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge)
Measure the number of observed bleeding events caused by the anticoagulation treatment
次要结局
- Anticoagulation drug dosage(Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge))
- Patients' compliance to anticoagulation treatment(Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge))
- Anticoagulation drug agent(Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge))
- Anticoagulation drug duration(Each subject's participation will last from inclusion (enrolment visit) to follow up visit (if applicable; four weeks post hospital discharge))
研究者
Nikolaos Ziras
Head of Oncology Clinic
Metaxa Hospital