Skip to main content
OpenTrials
Completed

NCT Number: NCT00199602

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oncologie Médicale

Limoges, 87000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

warfarine - low molecular heparin

Drug

Primary outcomes

  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 :

    Time frame: Day90

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

    Time frame: Day90

Secondary outcomes

  1. - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -

    Time frame: Day90

  2. - Frequency of other symptomatic venous thromboembolic events between 3 groups.

    Time frame: J0, J1, J21, J42, J63 and J90

  3. Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose

    Time frame: Day90

  4. -Costs in the 3 strategies

    Time frame: J90

  5. - Tumoral response to chemotherapy in the 3 groups.

    Time frame: Day90

  6. - Overall survival in each group.

    Time frame: Day90

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2009
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.