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

Trio Grup Clinical Research

Status: Unknown

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Industry

Identifiers

NCT02017743

TREBECA

Details and patient eligibility

About

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.

Full 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 :

1. Patients with active bleeding or at-risk for bleeding
2. Major surgery in the last 7 days
3. Cardiopulmonary unstability
4. Severe systemic venous occlusion
5. Patients at high risk for pulmonary embolism
6. Thrombocytopenia (<50000/microliter)
7. Inpatients under medical or surgery supervision
8. Patients with low ability to communicate and for whom it is not possible to provide care at home
9. INR≥1.5 due to liver functions impairment
10. Diagnosed for cerebral vascular aneurism
11. Active gastric and/or duodenum ulcer
12. Diagnosed for bacterial endocarditis
13. Severe renal function impairment (Creatinine clearance < 30 ml/min)
14. Grade 3 hypertension (DBP >= 110 mmHg and/or SBP >= 180 mmHg)
15. <35 kg or ≥110 kg weight
16. Known allergy to heparin and/or its derivatives
17. History of cerebrovascular event in the last 1 month
18. Active haemorrhage within the last 3 months

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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