Status:
COMPLETED
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Lead Sponsor:
University Hospital, Limoges
Conditions:
Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00199602
Start Date
August 1 1999
End Date
December 1 2010
Last Update
August 24 2018
Active Locations (1)
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1
Oncologie Médicale
Limoges, France, 87000