The primary objective of the TEAM-VTE study is to assess and specify the rate of new-onset abnormal menstrual bleeding in female in their fertile age, anticoagulated for an incident case of venous thromboembolism (VTE).The secondary objectives of…
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Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The risk of abnormal menstrual bleeding in women with childbearing potential
treated with anticoagulant drugs is increased, although solid studies to
quantify the prevalence of abnormal menstrual bleeding or the treatment thereof
are lacking to date. This issue is mostly relevant for patients with venous
thromboembolism (VTE), i.e. deep vein thrombosis (DVT) or acute pulmonary
embolism (PE), because other diseases that necessitates active anticoagulant
treatment are rare in female patients in the age category 18 to 50 years. In
general, abnormal menstrual bleeding is associated with negative perceptions
and limited social and professional activities as well with a significant
poorer quality of life compared with patients with normal menstrual bleeding.
Several specific aspects are especially relevant for the occurrence of
abnormal menstrual bleeding in anticoagulated female VTE patients, i.e. choice
of anticoagulation therapy, use of hormonal contraception (HC) and treatment of
abnormal menstrual bleeding. While on one hand Direct oral anticoagulant
(DOACs) have been associated with a lower overall bleeding risk - in particular
significantly lower fatal and intracranial bleeding - compared to the
conventional treatment of VTE being vitamin k antagonists (VKA), the risk of
abnormal uterine bleeding in women treated with factor Xa inhibitors has been
reported to be higher than with VKAs.The underlying mechanism for the
difference in these bleeding patterns is yet unknown. With DOACs being
recommended as the treatment of first choice for VTE, more and more female
patients with childbearing potential may suffer from even higher risks of
abnormal menstrual bleeding. Because most data on this subject originates from
post-hoc analysis, there is currently no sound scientific evidence for
providing recommendations with regard to the optimal anticoagulant regimen in
VTE patients of childbearing age.
The use of HC is common among women of childbearing age and associated
with a higher risk of VTE. Patients with hormone-associated VTE receive
anticoagulant treatment for at least three months and are instructed to
discontinue HC, as the risk of VTE recurrence is low after discontinuation of
hormonal therapy.The optimal timing of HC withdrawal is however uncertain since
HC may be conceived as risk factor for recurrent VTE during anticoagulant
treatment, although this is not supported by available evidence. Notably,
hormonal treatment with HC is often required to reduce the severity of abnormal
menstrual bleeding.5 Studies focussing on treatment of abnormal menstrual
bleeding in anticoagulated patients are scarce and of poor quality with low
patients numbers and often retrospective data acquisition. Available data
confirms the aggravating effect of anticoagulant treatment on the menstrual
bleeding pattern and the potential protective effect of a progestin-releasing
intra uterine devices. Studies evaluating other interventions such as
tranexamic acid are lacking, although this treatment is being applied in
clinical practice.
Study objective
The primary objective of the TEAM-VTE study is to assess and specify the rate
of new-onset abnormal menstrual bleeding in female in their fertile age,
anticoagulated for an incident case of venous thromboembolism (VTE).
The secondary objectives of the TEAM-VTE study are:
1. To assess the predictors of new-onset abnormal menstrual bleeding in
anticoagulated female VTE patients in their fertile age;
2. To assess the impact of new-onset abnormal menstrual bleeding in
anticoagulated female VTE patients in their fertile age on quality of life;
3. To assess the results of routine counselling and clinical work-up of
anticoagulated female VTE patients in their fertile age with new-onset abnormal
menstrual bleeding;
4. To assess the reasons for and consequences of modifications in contraceptive
measures and anticoagulant treatment in female VTE patients in their fertile
age;
5. To assess the association of use of oral contraceptives and new-onset
abnormal menstrual bleeding, other bleeding and recurrent VTE in female VTE
patients in their fertile age
Study design
This study is an international, multicenter, academically sponsored,
observational study, that focusses on fertile female patients with proven
symptomatic deep vein thrombosis of the legs (DVT) or acute pulmonary embolism
(PE). The incidence and severity of abnormal menstrual bleeding will be
assessed for each menstrual period and correlated to quality of life. Causes of
abnormal menstrual bleeding other than active anticoagulant treatment will be
assessed. Treatment of abnormal menstrual bleeding (all within routine clinical
care) will be evaluated for efficacy and safety.
Study burden and risks
This is an observational study; patients do not have direct benefits of
participating in this study other than helping in increasing our knowledge of
the subject under study. The burden of the study is limited and includes
completing a menstrual score chart every menstrual cycle and a quality of life
questionnaire at the end of the study. Two lay persons/patient representatives
have been involved in the study design and have indicated that the burden is
low. Patients are not expected to experience harm from study participation.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64567.058.17 |
| Other | Volgt |