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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: warfarine - low molecular heparin

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Oncologie Médicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: lack of drug prophylaxis
Experimental: HBPM 2500 UI anti Xa in one subcutaneous injection per day	Drug: warfarine - low molecular heparin
Experimental: warfarine 1mg daily	Drug: warfarine - low molecular heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy	Day90

Secondary Outcome Measures

Outcome Measure	Time Frame
- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -	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
- Overall survival in each group.	Day90

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Publications and helpful links

General Publications

• Lavau-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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 1999
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: I99006