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Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding (TEAM-VTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748393
Recruitment Status : Terminated (Low enrolment)
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Erik Klok, Leiden University Medical Center

Study Description
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Brief 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). 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.

Condition or disease
Venous Thromboembolism

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
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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding in Female Patients With VTE
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients within their fertile age, diagnosed with acute venous thromboembolism
Sampling Method:   Probability Sample
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.
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;

    1. 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);
    2. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748393


Locations
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Austria
Medical University Hospital
Vienna, Austria
France
Hôpital de la Cavale Blanche
Brest, France
CHU Saint-Etienne
Saint-Étienne, France
Germany
University Medical Centre Mannheim
Mannheim, Germany
Netherlands
Leiden University Medical Center
Leiden, Netherlands
Switzerland
Geneva University Hospital
Geneva, Switzerland
United Kingdom
Guy's & St Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: F.A. Klok LUMC Leiden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erik Klok, principal investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04748393    
Other Study ID Numbers: LUMC2017132
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik Klok, Leiden University Medical Center:
menorrhagia
anticoagulation
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases