Risk, predictors, impact and outcome of anticoagulation-associated abnormal menstrual bleeding in female patients with VTE * the TEAM-VTE study

Completed

Conditions: venous thromboembolism
venous thrombosis
10014523

Registration Number: NL-OMON55518

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

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

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of the TEAM-VTE study is the incidence of new-onset<br /><br>abnormal menstrual bleeding. Abnormal menstrual bleeding is binary defined as<br /><br>1) self-reported increased menstrual volume (regardless of regularity,<br /><br>incidence, or duration) according to the FIGO classification or 2) a PBAC score<br /><br>>100.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of the TEAM-VTE study include:<br /><br>1) Rate of clinical relevant non-major and major (menstrual) bleeding according<br /><br>to the ISTH criteria;<br /><br>2) Change in rate of abnormal menstrual bleeding after diagnosis of VTE<br /><br>compared to last 3 months before initiation of anticoagulants, and during the<br /><br>follow-up period.<br /><br>3) Impact of new-onset abnormal menstrual bleeding on QoL as assessed with the<br /><br>MBQ and PEmb-QoL;<br /><br>4) Predictors of new-onset abnormal menstrual bleeding;<br /><br>5) Changes in contraceptive measures during the study: details, incidence,<br /><br>causes and effect on primary endpoint and recurrent VTE;<br /><br>6) Changes in anticoagulation therapy: details, incidence, causes and effect on<br /><br>primary endpoint and recurrent VTE;<br /><br>7) Presence of underlying gynaecological or other morbidities as explanation<br /><br>for abnormal menstrual bleeding.</p><br>

Related Trials