venous thromboembolism venous thrombosis
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 drugs); 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the TEAM-VTE study is the incidence of new-onset abnormal menstrual bleeding. Abnormal menstrual bleeding is binary defined as 1) self-reported *increased menstrual volume* (regardless of regularity, incidence, or duration) according to the FIGO classification or 2) a PBAC score >100. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the TEAM-VTE study include: 1) Rate of clinical relevant non-major and major (menstrual) bleeding according to the ISTH criteria; 2) Change in rate of abnormal menstrual bleeding after diagnosis of VTE compared to last 3 months before initiation of anticoagulants, and during the follow-up period. 3) Impact of new-onset abnormal menstrual bleeding on QoL as assessed with the MBQ and PEmb-QoL; 4) Predictors of new-onset abnormal menstrual bleeding; 5) Changes in contraceptive measures during the study: details, incidence, causes and effect on primary endpoint and recurrent VTE; 6) Changes in anticoagulation therapy: details, incidence, causes and effect on primary endpoint and recurrent VTE; 7) Presence of underlying gynaecological or other morbidities as explanation for abnormal menstrual bleeding. | — |
Countries
Netherlands
Outcome results
None listed