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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University Hospital, Limoges.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00199602
First received: September 14, 2005
Last updated: December 30, 2008
Last verified: December 2008

September 14, 2005
December 30, 2008
August 1999
December 2009   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00199602 on ClinicalTrials.gov Archive Site
  • - 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.
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cancer
Drug: warfarine - low molecular heparin
Not Provided
Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Vénat-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Nicole TUBIANA-MATHIEU, MD +33(0) 555 056 396 oncologie@chu-limoges.fr
France
 
NCT00199602
I99006
No
Madame Marie SENGELEN/Directrice des Affaires Médicales et de la recherche Clinique, Chu Limoges
University Hospital, Limoges
Not Provided
Principal Investigator: Nicole TUBIANA-MATHIEU, MD University Hospital, Limoges
University Hospital, Limoges
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP