Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).

Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Heparin

Criteria

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