Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Phase 3
Completed
- Conditions
- Cancer
- Interventions
- Drug: warfarine - low molecular heparin
- Registration Number
- NCT00199602
- Lead Sponsor
- University Hospital, Limoges
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBPM 2500 UI anti Xa in one subcutaneous injection per day warfarine - low molecular heparin - warfarine 1mg daily warfarine - low molecular heparin -
- Primary Outcome Measures
Name Time Method Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy Day90 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 : Day90
- Secondary Outcome Measures
Name Time Method - Overall survival in each group. Day90 - Frequency of other symptomatic venous thromboembolic events between 3 groups. J0, J1, J21, J42, J63 and J90 Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose Day90 -Costs in the 3 strategies J90 - Tumoral response to chemotherapy in the 3 groups. Day90 - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. - Day90
Trial Locations
- Locations (1)
Oncologie Médicale
🇫🇷Limoges, France