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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
France
CHRU Brest
RECRUITING
Brest
HIA
RECRUITING
Brest
Clermont Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CH Morlaix
RECRUITING
Morlaix
Paris HEGP
NOT_YET_RECRUITING
Paris
RENNES
RECRUITING
Rennes
Saint Etienne
RECRUITING
Saint-etienne
Tours
RECRUITING
Tours
Contact Information
Primary
Francis Couturaud, MD, PHD
francis.couturaud@chu-brest.fr
33 2 98 34 73 47
Time Frame
Start Date: 2017-10-24
Estimated Completion Date: 2026-10-24
Participants
Target number of participants: 2640
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov