NCT01803022

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

February 26, 2013

Last Update Submit

February 1, 2018

Conditions

Keywords

Venous ThromboembolismCancerLow Molecular Weight Heparin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • To evaluate Venous Thromboembolism recurrences, bleeding, thrombocytopenia and deaths during Low Molecular Weight Heparin treatment

    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

    up to 6 months

  • To evaluate the anticoagulant treatment perception and satisfaction by patients with cancer disease with a validated questionnaire

    up to 6 months

Study Arms (1)

Low Molecular Weight Heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • \- Contraindication to the use of Low Molecular Weight Heparin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Conditions

Venous ThromboembolismNeoplasms

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Dominique Farge Bancel, Pr

    Groupe Francophone Thrombose et Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 4, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations