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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01803022
Other study ID # Tropique
Secondary ID
Status Completed
Phase N/A
First received February 26, 2013
Last updated February 1, 2018
Start date November 2012
Est. completion date July 2013

Study information

Verified date February 2018
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 419
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hopital Saint Louis Paris

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 6 months
Secondary 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. up to 6 months
Secondary To evaluate Venous Thromboembolism recurrences, bleeding, thrombocytopenia and deaths during Low Molecular Weight Heparin treatment up to 6 months
Secondary 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 up to 6 months
Secondary To evaluate the anticoagulant treatment perception and satisfaction by patients with cancer disease with a validated questionnaire up to 6 months
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