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Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Cancer

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Trial Information

Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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 :

Principal Investigator

Nicole TUBIANA-MATHIEU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Limoges

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

I99006

NCT ID:

NCT00199602

Start Date:

August 1999

Completion Date:

December 2009

Related Keywords:

  • Cancer
  • Thrombosis

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