Clinical trial · Interventional
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
NCT00199602CI-TRIAL-00034553completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| warfarine - low molecular heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- lack of drug prophylaxis
- type
- EXPERIMENTAL
- label
- HBPM 2500 UI anti Xa in one subcutaneous injection per day
- interventionNames
- Drug: warfarine - low molecular heparin
- type
- EXPERIMENTAL
- label
- warfarine 1mg daily
- interventionNames
- Drug: warfarine - low molecular heparin
Primary outcomes (2)
- measure
- 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 :
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1. PMID 23636449