Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
ConditionVenous Thromboembolic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorUniversity Hospital, Brest
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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)
Trial design
Design model
Family-based
Time perspective
Cross-sectional
Treatments tested in this trial
Case group
Other interventionQuestionnaire to be completed, blood sample and possibly echo-doppler
Control group
Other interventionQuestionnaire to be completed, blood sample and possibly echo-doppler
Treatment groups
2,640 Participants
are divided into 2 treatment groupsGroup A: Case group1 intervention
Group B: Control group1 intervention
Trial outcomes
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
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov