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

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ClinicalTrials.gov Identifier: NCT00199602
Recruitment Status : Unknown
Verified December 2008 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : December 31, 2008
Sponsor:
Information provided by:

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


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : August 1999
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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 :
  2. Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy

Secondary Outcome Measures :
  1. - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
  2. - Frequency of other symptomatic venous thromboembolic events between 3 groups.
  3. Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
  4. -Costs in the 3 strategies
  5. - Tumoral response to chemotherapy in the 3 groups.
  6. - Overall survival in each group.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00199602


Contacts
Contact: Nicole TUBIANA-MATHIEU, MD +33(0) 555 056 396 oncologie@chu-limoges.fr

Locations
France
Oncologie Médicale Recruiting
Limoges, France, 87000
Contact: Nicole TUBIANA-MATHIEU, MD         
Principal Investigator: Nicole TUBIANA-MATHIEU, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Nicole TUBIANA-MATHIEU, MD University Hospital, Limoges
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Madame Marie SENGELEN/Directrice des Affaires Médicales et de la recherche Clinique, Chu Limoges
ClinicalTrials.gov Identifier: NCT00199602     History of Changes
Other Study ID Numbers: I99006
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

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