Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism - An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.
Time Frame: [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 Frame: [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 Frame: [Time to bleeding in 15 days]
Secondary Outcomes
No secondary outcomes reported