Back to resultsProphylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Primary Purpose
Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
warfarine - low molecular heparin
Sponsored by
About this trial
This is an interventional prevention trial for Cancer
Eligibility Criteria
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
Sites / Locations
- Oncologie Médicale
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
lack of drug prophylaxis
HBPM 2500 UI anti Xa in one subcutaneous injection per day
warfarine 1mg daily
Arm Description
Outcomes
Primary Outcome Measures
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 :
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
Secondary Outcome Measures
- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
- Frequency of other symptomatic venous thromboembolic events between 3 groups.
Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
-Costs in the 3 strategies
- Tumoral response to chemotherapy in the 3 groups.
- Overall survival in each group.
Full Information
NCT ID
NCT00199602
First Posted
September 14, 2005
Last Updated
August 22, 2018
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT00199602
Brief Title
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
Official Title
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 1999 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lack of drug prophylaxis
Arm Type
No Intervention
Arm Title
HBPM 2500 UI anti Xa in one subcutaneous injection per day
Arm Type
Experimental
Arm Title
warfarine 1mg daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
warfarine - low molecular heparin
Primary Outcome Measure Information:
Title
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 :
Time Frame
Day90
Title
Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
Time Frame
Day90
Secondary Outcome Measure Information:
Title
- Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
Time Frame
Day90
Title
- Frequency of other symptomatic venous thromboembolic events between 3 groups.
Time Frame
J0, J1, J21, J42, J63 and J90
Title
Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
Time Frame
Day90
Title
-Costs in the 3 strategies
Time Frame
J90
Title
- Tumoral response to chemotherapy in the 3 groups.
Time Frame
Day90
Title
- Overall survival in each group.
Time Frame
Day90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole TUBIANA-MATHIEU, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncologie Médicale
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23636449
Citation
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.
Results Reference
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Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
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