NCT03206372 Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
| NCT ID | NCT03206372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Venous Thromboembolic Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,640 participants |
| Start Date | 2017-10-24 |
| Primary Completion | 2026-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,640 participants in total. It began in 2017-10-24 with a primary completion date of 2026-10-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 * 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. Exclusion criteria * 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 & Investigator
Francis Couturaud, MD, PhD
PRINCIPAL INVESTIGATOR
EA3878 (GETBO), Brest University Hospital in France
Frequently Asked Questions
Who can join the NCT03206372 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Venous Thromboembolic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03206372 currently recruiting?
Yes, NCT03206372 is actively recruiting participants. Contact the research team at francis.couturaud@chu-brest.fr for enrollment information.
Where is the NCT03206372 trial being conducted?
This trial is being conducted at Brest, France, Brest, France, Clermont-Ferrand, France, Morlaix, France and 4 additional locations.
Who is sponsoring the NCT03206372 clinical trial?
NCT03206372 is sponsored by University Hospital, Brest. The principal investigator is Francis Couturaud, MD, PhD at EA3878 (GETBO), Brest University Hospital in France. The trial plans to enroll 2,640 participants.