Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
Inclusion Criteria:
- First line chemotherapy for solid tumor with:
- Metastatic disease or
- Involved nodes or
- Unresectable tumor
- Indication for Implantable device for central venous access
- Potential survival > 3 months
- ECOG performance status 0 to 2 (WHO)
- Age between 18 and 75 years.
- Social security guaranteed
- Normal laboratory assessments (platelets> 100000/mm3, TP 60%, spontaneous TCA with
M/T<1.5, TGO and TGP < 2xN, serum creatinin<120µmol/l)
- Informed consent signed
Exclusion Criteria:
- Inability to understand informed consent or interfering with compliance for treatment
or protocol Anti-coagulant treatment -related criteria
- Acute infectious endocarditis
- History related with heparin allergy or thrombopenia due to heparin
- Uncontrolled high blood pressure (systolic blood pressure >180 mm Hg and/or diastolic
blood pressure >110 mm Hg)
- Hemorrhagic syndrome ongoing
- Patient with platelet inhibitors treatment
- Chronic, daily treatment with anti-coagulant therapy (LMWH or AVK), use as preventive
or curative level
- Patient with liver failure (TP<60%) or renal insufficiency (creatinin clearance< 20
ml/mn)
- Women with pregnancy and lactating Pathology-related criteria
- deep venous thrombosis history or pulmonary embolism (< 6 months)
- Clinical suspicious of brain metastasis