Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis. |  | [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. |  | [Time to resolution in 15 days] | 
| Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding |  | [Time to bleeding in 15 days] |