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

This study is currently recruiting participants.
Verified by University Hospital, Limoges, September 2005

Sponsored by: University Hospital, Limoges
Information provided by: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00199602
  Purpose

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 Intervention Phase
Cancer
Drug: warfarine - low molecular heparin
Phase III

MedlinePlus related topics:   Blood Thinners    Cancer   

Drug Information available for:   Heparin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study

Further study details as provided by University Hospital, Limoges:

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.

Estimated Enrollment:   420
Study Start Date:   August 1999

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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


Study ID Numbers:   I99006
First Received:   September 14, 2005
Last Updated:   December 14, 2005
ClinicalTrials.gov Identifier:   NCT00199602
Health Authority:   France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Vascular Diseases
Heparin
Thrombosis
Calcium heparin

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2008




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