Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

February 1, 2018 updated by: LEO Pharma
The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital Saint Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men or women aged 18 years or more with on-going cancer and recent diagnosis of Venous Thromboembolism, treated with Low Molecular Weight Heparin before entry into the study

Description

Inclusion Criteria:

  • Subjects must provide informed consent
  • Men or women aged 18 years or more
  • Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study

Exclusion Criteria:

- Contraindication to the use of Low Molecular Weight Heparin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Low Molecular Weight Heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prescription conditions and use of Low Molecular Weight Heparin in the French usual practice for the treatment of symptomatic Venous Thromboembolism in patients with cancer at up to 6 months
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the consistency of the Low Molecular Weight Heparin use with French national recommendations on the treatment of Venous Thromboembolism in patients with cancer.
Time Frame: up to 6 months
up to 6 months
To evaluate Venous Thromboembolism recurrences, bleeding, thrombocytopenia and deaths during Low Molecular Weight Heparin treatment
Time Frame: up to 6 months
up to 6 months
To describe clinical factors associated with treatment duration with Low Molecular Weight Heparin and those associated with the occurrence of Venous Thromboembolism in patients with cancer
Time Frame: up to 6 months
up to 6 months
To evaluate the anticoagulant treatment perception and satisfaction by patients with cancer disease with a validated questionnaire
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: Dominique Farge Bancel, Pr, Groupe Francophone Thrombose et Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tropique

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe