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

U

University of Limoges (UL)

Status and phase

Completed
Phase 3

Conditions

Cancer

Treatments

Drug: warfarine - low molecular heparin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

420 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

420 participants in 3 patient groups

lack of drug prophylaxis
No Intervention group
HBPM 2500 UI anti Xa in one subcutaneous injection per day
Experimental group
Treatment:
Drug: warfarine - low molecular heparin
warfarine 1mg daily
Experimental group
Treatment:
Drug: warfarine - low molecular heparin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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