Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,640
- 试验地点
- 12
- 主要终点
- Presence of venous thromboembolic disease in first-degree relatives.
研究概览
简要总结
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.
详细描述
Rational
The annual incidence of venous thromboembolism (VTE) is about 1 to 2/1000 person-years and mortality is 10% when VTE occurs as pulmonary embolism. VTE is a multifactorial disease caused by hereditary and acquired risk factors. Among the latter, hormonal exposure in young women (estrogen-containing pill, pregnancy) remains a major health issue given the frequency of this condition and the 4 to 5-fold increased risk of VTE in the presence of such exposure. In practice, inherited thrombophilia screening is often performed with the aim to identify young women at higher risk for VTE and to avoid estrogen-containing pill or to reinforce thromboprophylaxis during pregnancy. The increased risk of thrombosis in relatives is incompletely explained by the presence of known thrombophilias, as the risk of thrombosis in first-degree relatives is increased even if patients do not have a detectable defect.
In a large cross-sectional study including 2830 first-degree relatives of patients with VTE, we previously showed that the risk of VTE in the first-degree relatives of patients with a first VTE is strongly influenced by whether the VTE was provoked or unprovoked, the patient's age when the VTE occurred, and the number of relatives who have had thrombosis. The risk of VTE in first-degree relatives is about twice as high if the index case had an unprovoked compared to a provoked VTE, is about three times as high if the index case had VTE before about 50 years compared to later in life, and at least twice as high if two rather than one family members have had VTE. The influence of these factors on the risk of VTE in first-degree relatives was additive, and occurred independently of the presence of factor V Leiden or the prothrombin 20210A gene in index cases.
The underlying hypothesis is that patients who have unprovoked VTE or at a young age often have undetected hereditary thrombophilias and that these defects increase the risk of thrombosis in their relatives. However, the number of included young women in the study was to low to confirm if such familial risk was also elevated if young women were on hormonal exposure.
In the present study, our hypothesis is that the risk of VTE in first-degree relatives of young women with VTE on hormonal exposure will be higher than that in first-degree relatives of young women on a similar hormonal exposure without VTE, independently of the presence or not of a detectable inherited thrombophilia.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Control group (Other)
Case group
The cases are the first-degree family members of propositi having had an thromboembolic venous disease in hormonal context.
干预措施: Case group (Other)
结局指标
主要结局
Presence of venous thromboembolic disease in first-degree relatives.
时间窗: 1 day
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
次要结局
未报告次要终点