Trial | NCT00199602  Report issue

Title

Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    420
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
Study Started
Aug 31
1999
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2010
Last Update
Aug 24
2018

Drug warfarine - low molecular heparin

lack of drug prophylaxis No Intervention

HBPM 2500 UI anti Xa in one subcutaneous injection per day Experimental

warfarine 1mg daily Experimental

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
No Results Posted