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Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

A legfontosabb adatok

Ki végzi
University Hospital, Brest
Hol
Franciaország8 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
2640 fő, tervezett
Kezdés
2017. okt. 24.
Tervezett befejezés
2026. okt. 24.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • Case group
  • Control group
A regiszteradat frissítve
2026. június 16.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for close blood relatives (parents, brothers, sisters, children) of women aged 18 to 50. Some of these women had a first blood clot in a vein while taking estrogen-containing pills or while pregnant. The others had the same hormone exposure but never had a clot.

Életkor
16 years and older
Nem
All sexes
A betegség stádiuma
The woman in the family (aged 18-50) had a first clot in a deep vein of the leg or in the lung while on hormones. Scans must have confirmed it. Or she is a control woman with the same hormone exposure and no clot ever.
Korábbi kezelés
Relatives cannot join if the woman in their family took medicine to prevent clots during her pregnancy or while using contraception.

A részvétel fő kizáró okai

  • Relatives who had a clot only in a surface vein or a muscle vein
  • Relatives under 16 years of age
  • Vulnerable adults under guardianship or curatorship
  • No information can be obtained about the relatives
  • No health insurance

A regiszter feltételei, szó szerint

Mind a 10 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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
  • Family members under 16 years of age
  • Vulnerable persons other than minors aged 16 to 18 (guardianship, curatorship)
  • No information can be obtained on first-degree relatives
  • Not affiliated to or not benefiting from a health insurance scheme

Egyéb feltételek

  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • 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

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. június 16.