Venous ThromboembolismTEAM-VTENCT04748393
Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding
An observational study of Venous Thromboembolism, run by Leiden University Medical Center at 7 sites in 6 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 90 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 1 Sep 2018to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.
Who may be able to join
- Ability of subject to understand the character and individual consequences of this clinical study;
- Signed and dated informed consent of the subject available before the start of any specific study procedures;
- Age ≥18 years and ≤ 50 years;
- Confirmed symptomatic first or recurrent VTE;
- 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);
- 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;
- 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;
- Inclusion before the first day of next menstrual cycle after VTE diagnosis or within 1 month after the VTE diagnosis, whichever comes first.
Who cannot join
- Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
- Woman between the ages of 18 and 50 with premature menopause (established before study inclusion);
- Planned treatment with parenteral anticoagulation (and no switch to oral drugs);
- 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;
- Non-compliance or inability to adhere to the follow-up visits;
- Pregnancy or post-partum (first three months) associated VTE;
- Active in vitro fertilization (IVF) treatment or planned IVF treatment during the study period.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
France2 sites
Hôpital de la Cavale Blanche
Brest
CHU Saint-Etienne
Saint-Etienne
About this study
Official title: Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding in Female Patients With VTE
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.
Read the detailed description
A recently performed international survey of expert opinion and current practice revealed divergent expert recommendations and very heterogeneous management approach in clinical practice with regard to anticoagulation choice, use of HC and treatment of abnormal uterine bleeding during anticoagulant treatment of VTE. Together with the fact that up to 70% of female patients with childbearing potential treated with anticoagulants may suffer from abnormal menstrual bleeding with a severe negative impact on quality of life, this is a compelling argument to initiate high quality observational studies to better quantify the magnitude of the problem and to identify unmet clinical needs. This study will do so and at the same time provide solid ground for future prospective management trials aimed at establishing preventive and/or treatment strategies for VTE patients with anticoagulant-associated abnormal menstrual bleeding.
- Conditions
- Venous Thromboembolism
- Keywords
- menorrhagia, anticoagulation
- Medical subject headings
- Venous Thromboembolism, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
Rate of new-onset abnormal menstrual bleeding (PBAC >100 ml), and its impact on quality of life
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Sep 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Why it stopped: Low enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Klok, Leiden University Medical Center
- Investigators
- F.A. Klok, Principal investigator, LUMC Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748393
- Sponsor's protocol ID
- LUMC2017132
- Acronym
- TEAM-VTE
- Status last verified
- Feb 2021
- First submitted
- 14 Aug 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
de Jong CMM, Blondon M, Ay C, Buchmuller A, Beyer-Westendorf J, Biechele J, Bertoletti L, Colombo G, Donadini MP, Hendriks SV, Jara-Palomares L, Nopp S, Ruiz-Artacho P, Stephan P, Tromeur C, Vanassche T, Westerweel PE, Klok FA. Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism. Blood. 2022 Oct 20;140(16):1764-1773. doi: 10.1182/blood.2022017101.
PubMed 35925686
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding in Female Patients With VTE
- ClinicalTrials.gov ID
- NCT04748393
- Acronym / sponsor ID
- TEAM-VTE / LUMC2017132
- Conditions
- Venous Thromboembolism
- Keywords
- menorrhagia, anticoagulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrolment
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A recently performed international survey of expert opinion and current practice revealed divergent expert recommendations and very heterogeneous management approach in clinical practice with regard to anticoagulation choice, use of HC and treatment of abnormal uterine bleeding during anticoagulant treatment of VTE. Together with the fact that up to 70% of female patients with childbearing potential treated with anticoagulants may suffer from abnormal menstrual bleeding with a severe negative impact on quality of life, this is a compelling argument to initiate high quality observational studies to better quantify the magnitude of the problem and to identify unmet clinical needs. This study will do so and at the same time provide solid ground for future prospective management trials aimed at establishing preventive and/or treatment strategies for VTE patients with anticoagulant-associated abnormal menstrual bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | –Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Consecutive female patients between the ages of 18 and 50 with child bearing potential and objectivated, symptomatic VTE, who fulfil all the inclusion criteria and meet none of the exclusion criteria, are eligible for inclusion.
Key inclusion criteria (8 listed)
- Ability of subject to understand the character and individual consequences of this clinical study;
- Signed and dated informed consent of the subject available before the start of any specific study procedures;
- Age ≥18 years and ≤ 50 years;
- Confirmed symptomatic first or recurrent VTE;
- 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;
Key exclusion criteria (7 listed)
- Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
- Woman between the ages of 18 and 50 with premature menopause (established before study inclusion);
- Planned treatment with parenteral anticoagulation (and no switch to oral drugs);
- 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;
- Non-compliance or inability to adhere to the follow-up visits;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective
Time frame: 3-month follow-up
Rate of new-onset abnormal menstrual bleeding (PBAC >100 ml), and its impact on quality of life
Results and safety
The study was stopped early (reason given: Low enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 35925686de Jong CMM, Blondon M, Ay C, Buchmuller A, Beyer-Westendorf J, Biechele J, Bertoletti L, Colombo G, Donadini MP, Hendriks SV, Jara-Palomares L, Nopp S, Ruiz-Artacho P, Stephan P, Tromeur C, Vanassche T, Westerweel PE, Klok FA. Incidence and impact of anticoagulation-associated abnormal menstrual bleeding in women after venous thromboembolism. Blood. 2022 Oct 20;140(16):1764-1773. doi: 10.1182/blood.2022017101.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F.A. Klok principal investigator
LUMC Leiden
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Leiden University Medical Center at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Austria, Germany, Netherlands, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.