Investigating risk factors for blood clots in women using hormonal treatments

Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure

This study is trying to find out if family history affects the risk of blood clots in young women who use hormonal treatments like birth control or are pregnant.

Quick facts

• Study type: Observational
• Enrollment: 2640 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University Hospital, Brest (other)
• Locations: 8 sites (Brest and 7 other locations)
• Trial ID: NCT03206372 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify risk factors for venous thromboembolism (VTE) in young women exposed to hormones, such as those using estrogen-containing contraceptives or during pregnancy. It compares the prevalence of VTE in first-degree relatives of women who experienced VTE during hormonal exposure with those who did not. The study seeks to understand the influence of family history on VTE risk, potentially leading to better screening and prevention strategies for at-risk women. By analyzing data from a large cohort, the study hopes to clarify the role of hereditary factors in VTE occurrences.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 to 50 who have experienced a first episode of VTE while on hormonal treatment and their first-degree relatives.

Not a fit: Patients who have received preventive antithrombotic medication during pregnancy or contraception may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for young women at risk of VTE during hormonal exposure.

How similar studies have performed: Previous studies have indicated a strong familial influence on VTE risk, suggesting that this approach may yield valuable insights.

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.

Where this trial is running

Brest and 7 other locations

• CHRU Brest — Brest, France (RECRUITING)
• HIA — Brest, France (RECRUITING)
• Clermont Ferrand — Clermont-Ferrand, France (NOT_YET_RECRUITING)
• CH Morlaix — Morlaix, France (RECRUITING)
• Paris HEGP — Paris, France (NOT_YET_RECRUITING)
• RENNES — Rennes, France (RECRUITING)
• Saint Etienne — Saint-Etienne, France (RECRUITING)
• Tours — Tours, France (RECRUITING)

Study contacts

• Principal investigator: Francis Couturaud, MD, PhD — EA3878 (GETBO), Brest University Hospital in France
• Study coordinator: Francis Couturaud, MD, PHD

Conditions: Venous Thromboembolic Disease