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

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Status Verified: 2008-12
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-24

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
- 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
- Overall survival in each group.	Day90

Trial Locations

Locations (1)

Oncologie Médicale; 🇫🇷 Limoges, France