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National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients (CARMEN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362933
First Posted: June 1, 2011
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre Hospitalier Universitaire, Amiens
Groupe Francophone Thrombose et Cancer (GFTC)
University Hospital, Grenoble
Information provided by (Responsible Party):
Floralis
  Purpose
Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.

Condition Intervention
Neoplasms Venous Thromboembolism Procedure: VTE treatment in cancer patient description

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Evaluation of the Adherence to Recommendations of VTE Treatment in Cancer Patients

Further study details as provided by Floralis:

Primary Outcome Measures:
  • Evaluation of the adherence to recommendations of VTE treatment in cancer patients [ Time Frame: At baseline (J0) ]
    Proportion of patients treated for evolutive VTE according to international recommandations Patients could be hospitalised or could be out patient


Secondary Outcome Measures:
  • Evaluation of VTE disease according to cancer diagnosis (proportion of SVT (Superficial Venous Thrombosis), DVT (Deep Venous Thrombosis), PE (Pulmonary Embolism) [ Time Frame: At baseline (J0) ]
    Percentage of VTE (PE,DVT,SVT)and cancer type

  • Proportion of asymptomatic VTE disease for this population [ Time Frame: At baseline (J0) ]
    percentage of VTE and cancer status (local, metastatic)

  • Feasibility of self injections for VTE treatment in cancer patients. [ Time Frame: At baseline (J0) ]
    percentage of patients practising self injections

  • Proportion of patients with catheter thrombosis [ Time Frame: At baseline (J0) ]
    Percentage of patients receiving novel cancer therapies


Enrollment: 502
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VTE treatment in cancer patient
All patients with cancer present in the clinic, hospital, out patient diagnosed with a VTE during the 6 previous months.
Procedure: VTE treatment in cancer patient description
proportion of patients treated for evolutive VTE according to international recommendations

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months
Criteria

Inclusion Criteria:

All patients with cancer present in the clinic, hospital, out patients diagnosed with a VTE during the 6 previous months. VTE can be symptomatic or asymptomatic, can be located close to a central line, and of any type (DVT, PE, SVT)

Exclusion Criteria:

  • Patient already included in a trial studying antithrombotic therapy
  • Patient refusing the study
  • Patient under 18 and/or not competent to give informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362933


  Show 49 Study Locations
Sponsors and Collaborators
Floralis
Centre Hospitalier Universitaire, Amiens
Groupe Francophone Thrombose et Cancer (GFTC)
University Hospital, Grenoble
Investigators
Principal Investigator: Marie-Antoinette SEVESTRE, MD Centre Hospitalier Universitaire, Amiens
Study Director: Dominique FARGE BANCEL, MD GFTC
Study Director: Jean Luc BOSSON, MD University Hospital, Grenoble
  More Information

Additional Information:
Publications:

Responsible Party: Floralis
ClinicalTrials.gov Identifier: NCT01362933     History of Changes
Other Study ID Numbers: Version N°2.0 du 21/03/2011
First Submitted: May 25, 2011
First Posted: June 1, 2011
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Floralis:
PE
DVT
SVT
LMWH
VKA
international Venous Thromboembolism Recommendations

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases