NL-OMON55518已完成不适用
Risk, predictors, impact and outcome of anticoagulation-associated abnormal menstrual bleeding in female patients with VTE * the TEAM-VTE study - VTE-TEAM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Ability of subject to understand the character and individual consequences
- •of this clinical study;
- •2) Signed and dated informed consent of the subject available before the start
- •of any specific study procedures;
- •3) Age *18 years and * 50 years;
- •4) Confirmed symptomatic first or recurrent VTE;
- •a. DVT: incompressibility of proximal or distal veins of the affected leg by
- •compression ultrasonography or venous filling defect on multi-detector computed
- •tomography venography. The diagnosis of ipsilateral recurrent DVT is defined as
- •a CUS that shows incompressibility of a different venous segment than at the
- •reference CUS examination, or in case of a pronounced increase in vein diameter
- •(*4 mm) of a previous non-compressible venous segment, or by an abnormal signal
- •of Magnetic resonance direct thrombus imaging (MRDTI);
- •b. PE: both first and recurrent PE are diagnosed in case of at least one
- •filling defect in the pulmonary artery tree on multi-detector computed
- •tomography pulmonary angiography (CTPA) up to the subsegmental level, or high
- •probability result of ventilation perfusion scintigraphy;
- •5) Childbearing potential, i.e. with active menstrual cycle with or without
- •hormonal regulation of any kind initiated for reasons of either contraception
- •or for treatment of abnormal menstrual bleeding;
- •6) Inclusion before the first day of next menstrual cycle after VTE diagnosis
- •or within 1 month after the VTE diagnosis, whichever comes first.
排除标准
- •1) Woman between the ages of 18 and 50 who were subjected to hysterectomy or
- •chemically induced menopause;
- •2) Woman between the ages of 18 and 50 with premature menopause (established
- •before study inclusion);
- •3) Planned treatment with parenteral anticoagulation (and no switch to oral
- •4) Medical or psychological condition that would not permit completion of the
- •study or signing of informed consent, including life expectancy less than 6
- •months, or unwillingness to sign informed consent;
- •5) Non-compliance or inability to adhere to the follow-up visits;
- •6) Pregnancy or post-partum (first three months) associated VTE;
- •7) Active in vitro fertilization (IVF) treatment or planned IVF treatment
- •during the study period.
研究者
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