Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients (NCT00199602) | Clinical Trial Compass
CompletedPhase 3
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
France420 participantsStarted 1999-08
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
Timeframe: Day90
2
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy