Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
研究概览
简要总结
This study is a multicenter post authorization observational study. Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded. Since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria. Treatment protocol will be based on the routine treatment practice of the involved investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.
详细描述
Inclusion criteria
- 18 years or upper age
- A signed informed consent document
- Cancer patient diagnosed for VTE
- Life expectancy > 6 months
- Eligible for criteria of outpatient administration of LMWH
Exclusion criteria
• Should not carry any medical situation listed below, that outpatient administration of LMWH might be risky :
- Patients with active bleeding or at-risk for bleeding
- Major surgery in the last 7 days
- Cardiopulmonary unstability
- Severe systemic venous occlusion
- Patients at high risk for pulmonary embolism
- Thrombocytopenia (<50000/microliter)
- Inpatients under medical or surgery supervision
- Patients with low ability to communicate and for whom it is not possible to provide care at home
- INR≥1.5 due to liver functions impairment
- Diagnosed for cerebral vascular aneurism
- Active gastric and/or duodenum ulcer
- Diagnosed for bacterial endocarditis
- Severe renal function impairment (Creatinine clearance < 30 ml/min)
- Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- <35 kg or ≥110 kg weight
- Known allergy to heparin and/or its derivatives
- History of cerebrovascular event in the last 1 month
- Active haemorrhage within the last 3 months
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
- •18 years or upper age
- •A signed informed consent document
- •Cancer patient diagnosed for VTE
- •Life expectancy > 6 months
- •Eligible for criteria of outpatient administration of LMWH
排除标准
- •Patients with active bleeding or at-risk for bleeding
- •Major surgery in the last 7 days
- •Cardiopulmonary unstability
- •Severe systemic venous occlusion
- •Patients at high risk for pulmonary embolism
- •Thrombocytopenia (<50000/microliter)
- •Inpatients under medical or surgery supervision
- •Patients with low ability to communicate and for whom it is not possible to provide care at home
- •INR≥1.5 due to liver functions impairment
- •Diagnosed for cerebral vascular aneurism
- •Active gastric and/or duodenum ulcer
- •Diagnosed for bacterial endocarditis
- •Severe renal function impairment (Creatinine clearance < 30 ml/min)
- •Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
- •<35 kg or ≥110 kg weight
- •Known allergy to heparin and/or its derivatives
- •History of cerebrovascular event in the last 1 month
- •Active haemorrhage within the last 3 months
结局指标
主要结局
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
时间窗: [Time to new thrombosis in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.
时间窗: [Time to resolution in 15 days]
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding
时间窗: [Time to bleeding in 15 days]
次要结局
未报告次要终点