Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00199602
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Cancer Drug: warfarine - low molecular heparin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study
Actual Study Start Date : August 1999
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

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

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. - [ Time Frame: Day90 ]
  2. - Frequency of other symptomatic venous thromboembolic events between 3 groups. [ Time Frame: J0, J1, J21, J42, J63 and J90 ]
  3. Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose [ Time Frame: Day90 ]
  4. -Costs in the 3 strategies [ Time Frame: J90 ]
  5. - Tumoral response to chemotherapy in the 3 groups. [ Time Frame: Day90 ]
  6. - Overall survival in each group. [ Time Frame: Day90 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00199602

Oncologie Médicale
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Principal Investigator: Nicole TUBIANA-MATHIEU, MD University Hospital, Limoges

Publications of Results:
Responsible Party: University Hospital, Limoges Identifier: NCT00199602     History of Changes
Other Study ID Numbers: I99006
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: December 2008

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action