Actively Recruiting

Age: 16Years +
All Genders
Healthy Volunteers
ID03206372

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

Led by University Hospital, Brest · Updated on 2025-05-23

2640

Participants Needed

8

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Young women face an increased risk of venous thromboembolism (VTE) when exposed to hormones such as estrogen-containing pills or during pregnancy. This research compares the occurrence of VTE in first-degree relatives of women who had VTE during hormonal exposure with those whose relatives did not experience VTE under similar hormonal conditions. The study aims to better understand the influence of family history and inherited thrombophilia on VTE risk in this population. The study is a cross-sectional, case-control design involving two groups: first-degree relatives of women who had a VTE event related to hormonal exposure and relatives of women with similar hormonal exposure but no VTE. Participants in both groups complete questionnaires and provide blood samples; some may also undergo an echo-doppler exam. The research investigates the presence of VTE in these relatives and evaluates genetic factors like factor V Leiden and the prothrombin 20210A gene variant. Participants provide consent and undergo assessments including medical history questionnaires, blood tests, and possible imaging to detect previous VTE events. Researchers will evaluate the prevalence of symptomatic VTE in first-degree relatives and analyze associated hereditary factors. The primary outcome focuses on whether relatives have had venous thromboembolism, with data collected promptly on enrollment. The study duration and follow-up are based on initial assessments and data analysis periods.

CONDITIONS

Brief Title

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • First-degree relatives (parents, siblings, children) of women aged 18 to 50 who had a first venous thromboembolism (VTE) during hormonal exposure
  • First-degree relatives of matched women with similar hormonal exposure but no VTE
  • Written consent from both the women (propositi) and their first-degree relatives
  • Women (propositi) with objectively confirmed proximal deep vein thrombosis or pulmonary embolism during hormonal exposure
Not Eligible

You will not qualify if you...

  • First-degree relatives whose related woman received preventive antithrombotic medication during pregnancy or contraception
  • Family members who have had superficial or muscular venous thrombosis
  • No information available on first-degree relatives
  • Family members under 16 years old
  • Vulnerable persons other than minors aged 16 to 18 (guardianship, curatorship)
  • Not affiliated with or benefiting from a health insurance scheme

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 1 day

Participants complete a questionnaire, provide a blood sample, and may undergo an echo-doppler to assess venous thromboembolic disease status.

1 visit (in-person)

Trial Site Locations

Total: 8 locations

1

CHRU Brest

Brest, France, 29200

Actively Recruiting

2

HIA

Brest, France

Actively Recruiting

3

Clermont Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

4

CH Morlaix

Morlaix, France

Actively Recruiting

5

Paris HEGP

Paris, France

Not Yet Recruiting

6

RENNES

Rennes, France

Actively Recruiting

7

Saint Etienne

Saint-Etienne, France

Actively Recruiting

8

Tours

Tours, France

Actively Recruiting

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Research Team

F

Francis Couturaud, MD, PHD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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