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Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure (FIT-H)

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ClinicalTrials.gov Identifier: NCT03206372
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE during hormonal exposure, thrombophilia testing is often performed in order to adapt contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such practice is probably not accurate nor discriminent. Indeed, there are evidence that the impact of the familial history of VTE might be stronger than that of detectable inherited thrombophilia.

The "FIT-H" study is a cross-sectional study comparing the prevalence of previous venous thromboembolism in first-degree relatives of women (propositi) who had a first episode of venous thromboembolism in association with hormonal exposure with the prevalence of previous venous thromboembolism in first-degree relatives of women who did not have venous thromboembolism during a similar hormonal exposure.

The primary objective is to determine the association between the presence or the absence of VTE in young women during hormonal exposure and the presence or the absence of a previous episode of VTE in their first-degree relatives. Secondary objective is to determine the impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.


Condition or disease Intervention/treatment
Venous Thromboembolic Disease Other: Case group Other: Control group

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2640 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : October 24, 2020
Estimated Study Completion Date : October 24, 2020

Group/Cohort Intervention/treatment
Case group
The cases are the first-degree family members of propositi having had an thromboembolic venous disease in hormonal context.
Other: Case group
Questionnaire to be completed, blood sample and possibly echo-doppler

Control group
The controls are the first-degree family members of propositi who have never had an thromboembolic venous disease and have identical hormonal exposure
Other: Control group
Questionnaire to be completed, blood sample and possibly echo-doppler




Primary Outcome Measures :
  1. Presence of venous thromboembolic disease in first-degree relatives. [ Time Frame: 1 day ]

    The primary outcome measure is defined by the presence of symptomatic venous thromboembolic disease in first degree relatives based on:

    • objective, validated and standardized criteria
    • or a validated and standardized questionnaire and leg ultrasound according to a validated algorithm


Biospecimen Retention:   Samples With DNA
frozen plasma for DNA analysis (Factor V Leiden and prothrombin gene mutation) stored in central lab in Brest at -80°C.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Definitions

  • cases are first-degree relatives (i.e., parents, siblings, children) of young women who have VTE during hormonal exposure;
  • controls are first-degree relatives (i.e., parents, siblings, children) of young women who did not have VTE during a similar hormonal exposure;
  • study subjects are first-degree relatives
  • propositi are young women on hormonal exposure, whether VTE was present of not
  • hormonal exposure is defined by estrogen-containg pill exposure (ongoing or stopped from less than 3 months) or pregnancy or post-partum (in the three months following delivery), in the absence of other provoking risk factors (such as surgery, prolonged immobilization or trauma of lower limbs in the past three months, or cancer in the past 2 years)
Criteria

Eligibility criteria:

- Propositi with objectively confirmed proximal deep vein thrombosis (i.e. ultrasonography) or pulmonary embolism (i.e. lung scanning) in women (18 to 50 years) while on hormonal exposure.

Inclusion criteria

  • cases are first-degree relatives (i.e., parents, siblings, children) of young women (18 to 50 years) who have VTE during hormonal exposure;
  • controls are first-degree relatives (i.e., parents, siblings, children) of young women (18 to 50 years) who did not have VTE during a similar hormonal exposure;
  • the propositus is willing to provide written informed consent to participate in the study and to allow at least one of their first-degree relatives to be approached for the study;
  • First-degree relatives are eligible as study subjects if they are: a biological child, full sibling or biological parent of an index case; at least 16 years of age; and if they provided informed consent. *

Exclusion criteria

  • first-degree relative where the propositus had thromboprophylaxis during hormonal exposure or had VTE in association with other provoking risk factors (surgery, trauma, prolonged immobilization, cancer, as defined above)
  • No information can be obtained on first degree family members.
  • Family member under 16 years of age.
  • Vulnerable person other than minors aged 16 to 18 (person placed in guardianship, curatorship)
  • Not affiliated with and not beneficiary of a health insurance scheme.

    • First-degree relatives who were dead could be included as study subjects provided the index case agreed, and information about previous VTE was available.

Index cases will be enrolled prospectively at six university hospitals in France when they will be diagnosed with a acute episode of acute symptomatic VTE.


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): NCT03206372


Contacts
Contact: Francis Couturaud, MD, PHD 33 2 98 34 73 47 francis.couturaud@chu-brest.fr

Locations
France
CHRU Brest Recruiting
Brest, France, 29200
Contact: Francis Couturaud, Professor    33 2 98 34 73 47    francis.couturaud@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Francis Couturaud, MD, PhD EA3878 (GETBO), Brest University Hospital in France

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03206372     History of Changes
Other Study ID Numbers: FIT-H (29BRC17.0063)
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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