Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
FIT-H
Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
1 other identifier
observational
2,640
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 24, 2026
May 23, 2025
May 1, 2025
9 years
June 30, 2017
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of venous thromboembolic disease in first-degree relatives.
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
1 day
Study Arms (2)
Case group
The cases are the first-degree family members of propositi having had an thromboembolic venous disease in hormonal context.
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
Interventions
Questionnaire to be completed, blood sample and possibly echo-doppler
Eligibility Criteria
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)
You may qualify if:
- First-degree relatives (biological parents, brothers, sisters, children) of women of childbearing age 18-50 years (propositus) with a first MVTE in the hormonal setting and matched control women in the same hormonal setting who have never had MVTE, consenting to first-degree relatives being contacted to participate in the present study.
- Written consent from propositi and family members.
You may not qualify if:
- First-degree relatives whose propositus received preventive antithrombotic medication during pregnancy or contraception.
- Family members of propositus who have had superficial or muscular venous thrombosis
- No information can be obtained on first-degree relatives.
- Family members under 16 years of age.
- Vulnerable persons other than minors aged 16 to 18 (guardianship, curatorship).
- Not affiliated to or not benefiting from a health insurance scheme.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHRU Brest
Brest, 29200, France
HIA
Brest, France
Clermont Ferrand
Clermont-Ferrand, France
CH Morlaix
Morlaix, France
Paris HEGP
Paris, France
RENNES
Rennes, France
Saint Etienne
Saint-Etienne, France
Tours
Tours, France
Biospecimen
frozen plasma for DNA analysis (Factor V Leiden and prothrombin gene mutation) stored in central lab in Brest at -80°C.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Couturaud, MD, PhD
EA3878 (GETBO), Brest University Hospital in France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 2, 2017
Study Start
October 24, 2017
Primary Completion (Estimated)
October 24, 2026
Study Completion (Estimated)
October 24, 2026
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share